Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Carda 2011

Type of study:

RCT

Setting:

Secondary rehabilitive care

Country:

Italy

Source of funding:

None

Inclusion criteria:

-   Hemiplegia after ischaemic or haemorrhagic stroke documented by CT scan

-   Time from stroke > 6 months

-   Equinovarus foot with spastic hypertonia of the triceps surae graded at least 1+ according to MAS

-   Ability to walk alone with/without aids and/or orthosis

-   last treatment at least 6 months before access to the department

Exclusion criteria:

-   presence of fixed contractures and/or bony deformities at the ankle;

-   need for treatment with BTA

to lower extremity muscles other than the triceps surae;

-   use of antispastic drugs such as baclofen or tizanidine;

-   cognitive impairment limiting the ability to understand motor tasks required during treatment;

-   concomitant progressive central nervous system disorders;

-   concomitant peripheral nervous system disorders/myopathies;

-   previous surgery at the plantar flexor muscles on the affected side.

N total at baseline: 69

Taping: 24

Casting: 27

Stretching: 18

Important prognostic factors²:

age ± SD:

Taping: 62,2 ± 11,7

Casting: 64,5 ± 12,5

Stretching: 59,6 ± 14,3

Sex:

Taping:54,2 % M

Casting: 44,4 % M

Stretching:61,1 % M

Time from stroke (months) ± SD

Taping: 46,9 ± 41,3

Casting: 52,3 ± 43,8

Stretching: 43,9 ± 39,6

Mean BTA dose (IU)

Taping: 235 (40)

Casting: 242 (48)

Stretching: 248 (32)

Groups comparable at baseline?

Yes

Botulinum toxin type A injection at the plantar flexors followed by

one week of taping or

one week of casting

followed by

stretching and gait training for the next week.

Casting: below knee fiberglass casts were applied with ankle in neutral supination/pronation and dorsiflexion.

Taping: adhesive taping at the ankle and thigh to stretch the injected muscles. The taping was maintained for five days and changed daily.

Botulinum toxin type A injection at the plantar flexors followed by

one week of stretching

followed by

stretching and gait training for the next week.

Stretching: program of 30 minutes of stretching of the calf twice a day.

Length of follow-up:

90 days

Loss-to-follow-up:

Taping: 1 (4,2%)

Reasons: discontinued because of pain

Casting: 1 (3,7%)

Reasons: discontinued because of pain and discomfort

Stretching: 0 (0%)

Incomplete outcome data:

Taping: 23 (95,8%)

Reasons not described

Casting: 23 (88,5%)

Reasons not described.

Stretching: 23 (127,8%)

Reasons not described.

Outcome measures and effect size:

Modified ashworth scale after 20 days : mean (SD)

Taping: 2,3 (0,8)

Casting: 1,3 (1,1)

Stretching: 2,5 (0,6)

Sign. reduction for all groups compared to baseline.

Taping not sign. better than stretching. P=0,34

Casting sign. Better than Stretching P=0.001 (95% CI 95% CI -1,70 to 0,70)

Modified ashworth scale after 90 days : mean (SD)

Taping: 2,8 (0,6)

Casting: 1,5 (1,2)

Stretching: 3,5 (0,8)

Sign. reduction for casting and taping compared to baseline.

Both taping and casting sign. better improvement than stretching. P<0,05

Casting sign. better than taping. P<0,05

PROM (degrees) after 20 days: mean (SD)

Taping: 3,8 (4,7)

Casting: 6,4 (14,3)

Stretching: 1,4 (3,6)

Sign. Improvement for casting and taping compared to baseline.

Both taping and casting not sign. better than stretching

PROM (degrees) after 90 days: mean (SD)

Taping: 2,2 (6)

Casting: 8,6 (13,2)

Stretching: -1,8 (2)

Casting sign. better than taping which was sign. better than stretching.

No serious adverse events.

Other adverse events:

Skin blisters (4 in taping group, 2 in casting group) recovered without sequelae.

Transitory oedema of the leg after removal of the tape (n=1) or cast (n=1).

Treatment after BTA administration to the ankle plantar flexors can significantly modify outcome.

Adjuvant casting or taping after BTA produced a greather and longer lasting effect of the toxin than stretching.

The favourable results remain longer when achieved with casting.

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Farina 2008

Type of study:

RCT

Setting:

Single centre study

Country:

Italy

Source of funding:

Not reported

Inclusion criteria:

-    first cerebrovascular stroke

equinovarus foot due to severe lower limb spasticity, at least grade 3 on MAS at calf muscles

impaired walking and ADL

ability to walk ≥ 10 meters with of without aid.

-    mean score on ESS ≥43/100

-    Barthel Index ≥55/100

Exclusion criteria:

-   Treatment with oral antispastic drugs four weeks prior to recruitment

-   previous treatment with BTA

-   severe fixed contractures impairing mobility

-   history of allergy

N total at baseline: 13

Intervention: 6

Control: 7

Important prognostic factors²:

For example

age ± SD:

I: 62 ± 11,83

C:65,6 ± 5,2

Sex:

I: 66,7% M

C: 42,9% M

ESS:

I: 63 ± 11,17

C: 60,57 ± 4,43

Groups comparable at baseline?

Yes

BTA injection (tibialis anterior and calf muscles) + ankle-foot casting (worn at night)

Rigid night-time made-to-measure ankle foot orthoses asts were worn for 4 months from 10 days after injection.

The talocrural joint was kept at maximum dorsiflexion (90°) without crossing the pain threshold.

BTA injection (tibialis anterior and calf muscles)

Length of follow-up:

4 months

Loss-to-follow-up:

Intervention: 0

Control: 0

Incomplete outcome data:

There were no incomplete outcome data

Outcome measures and effect size:

MAS

difference between score after 4 months vs baseline: mean (SD)

I: -0.58 ± 0.34

C: 0.428 ± 0.495

 P < 0.05

Randomisation not described, allocation concealment not described

Prolonged stretching of spastic muscles after BTA injection affords long-lasting therapeutic benefits, enhancing the effect of BTA injections alone.

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Copley 2013

Type of study:

Randomized, dinge blinded, single case design

Setting:

Single centre

Country:

Australia

Source of funding:

Motor Accident Insurance Commission +

Queensland Health Allied Health Grant Scheme

Inclusion criteria:

-   age 18-80 years

-   ≥ 2 months since injury

-   moderate stiffness in the wrist and/or hand flexor muscles of the affected upper limb/s, with a

 MAS score of 1+ or 2

-   presence of spasticity in the wrist or finger flexor muscles as indicated by a muscle reactivity

rating of at least 2 on the

MTS

-   no soft tissue contracture

in wrist or finger flexor muscles as indicated on the same scale.

Exclusion criteria:

-   cognitive or behavioural deficits that prevented (1) the provision of informed consent or (2) active participation in an upper

 limb therapy program.

N total at baseline: 10

Intervention: 6car

Control: 4

Important prognostic factors:

For example age ± SD:

I: 39,5 ± 16,05

C: 53,5 ± 6,45

Sex:

I: 66,7 % M

C: 50 % M

Groups comparable at baseline?

no, intervention group is younger and age variation is bigger.

Splint + usual therapy

The splint was an individualized, thermoplastic resting

mitt splint designed to approximate the standard resting position (20◦ wrist extension) but tailored if this resulted in observable excessive stretch.

The splint was worn 2-4 hours a day and overnight if necessary for a total of 3 months.

Usual therapy consisted of standard practice to patients with upper limb

hypertonicity (i.e. various combinations of movement training, stretches and functional splinting)

Usual therapy

Usual therapy consisted of standard practice to patients with upper limb

hypertonicity (i.e. various combinations of movement training, stretches and functional splinting)

Length of follow-up:

4 months

Loss-to-follow-up:

Intervention: 0

Control: 0

Incomplete outcome data:

There were no incomplete outcome data

Outcome measures and effect size:

PROM (degrees) wrist after 4 months: mean (SD)

I: 64.17 ± 5.33

C: 52.50 ± 5.59

[95% CI 4.73; 18.61] P ≤ 0,05

PROM (degrees) fingers after 4 months: mean (SD)

I: 56.67 ± 10.27

C: 46.25 ± 5.44

[95% CI -0.18; 2.55] P>0,05

MAS wrist after 4 months: mean (SD)

I: 1.42 ± 0.34

C: 1.50 ± 0.35

[95% CI -1,50; 1,03] P>0,05

MAS fingers after 4 months: mean (SD)

I: 1.75 ± 0.25

C: 2.13 ± 0.73

[95% CI: −2.08; 0.53] P>0,05

MTS wrist after 4 months

I: 44.17 ± 12.04

C: 57.50 ± 16.00

[95% CI: −2.31; 0.35] P>0,05

MTS fingers after 4 months

I: 85.00 ± 35.59

C: 98.75 ± 7.39

[95% CI: −1.76; 0.80] P>0,05

Adverse events: Not reported

Between group analysis showed that splinting has a positive effect on PROM of the wrist after 4 months.

There were no significant benefits for the intervention group regarding muscle stiffness (MAS) and spasticity angle (MTS).

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Santamato 2015

Type of study:

Randomized trial

Setting:

Single centre

Country:

Italy

Source of funding:

Programmi di Ricerca

Scientifica di Rilevante Interesse Nazionale (PRIN)

2009

Inclusion criteria:

-   stable upper limb

spasticity resulting from a stroke at least five months before the enrolment

-   MAS ≥ 2

Exclusion criteria before BTA injections:

-   fixed contractures and/or deformities at the shoulder, elbow, and wrist (muscle contracture was considered as severe restriction of the joint range of motion on passive

stretch)

-   previous fractures after stroke of the paretic upper limb

-   cognitive impairment

-   peripheral nervous system disorders/myopathies

-   medications that could have had an impact on the study findings (e.g. intrathecal baclofen, benzodiazepines, muscle relaxants, previous treatment of spasticity with phenol or alcohol injection or surgery in the target limb).

Exclusion criteria after BTA injections:

-    patients with fibrotic muscles graded III and IV at Heckmatt scale because less responsible to BTA treatment

N total at baseline: 70

Intervention: 35

Control: 35

Important prognostic factors2:

Age ± SD:

I: 55,9 ± 7,7

C: 57,9 ± 8,4

Sex:

I: 51,4 % M

C: 57,1 % M

Time from stroke (months) ± SD

I: 12,6 ± 3,8

C: 12,2 ± 3,2

Groups comparable at baseline?

Yes

BTA injections followed by

adhesive taping for 10 days

BTA injections

followed by

daily muscle manual stretching (30 min a day), passive articular mobilization of wrists and fingers and palmar splint (60 min. a day) for 10 days

Length of follow-up:

1 month

Loss-to-follow-up: Intervention: 0

Control: 0

Outcome measures and effect size:

mean (SD)

MAS fingers after 4 weeks:

I: 1.9 ± 0.7

C: 2.5 ± 0.6

P <0.001

MAS wrist after 4 weeks:

I: 2.0 ± 0.7

C: 2.6 ± 0.6

P <0.01

DAS after 4 weeks:

I: 1.6 ± 0.7

C: 2.1 ±0.7

P <0.01

Adverse events:

No serious adverse events

Significant better score in adhesive taping group regarding MAS fingers and wrist and DAS after both two and four weeks.

No control group (a group who received no therapy after BTA injection).

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Gracies 2000

Type of study:

Cross-over trial

Setting:

Outpatient and inpatient rehabilitation centre

Country:

USA

Source of funding:

None

Inclusion criteria:

-   18-85 years

-   Hemiparesis

-   Flexor and pronator spasticity in the upper limb caused by a stroke ≥ 3 weeks before study.

Exclusion criteria:

-   cognitive impairment, behavioral disturbance, or serious independent chronic disease likely to interfere with the ability to give informed consent or cooperate in the study, assessed by the physician

-   major contracture affecting muscles of the spastic arm at the time of recruitment;

-   cutaneous or joint pathologic states in the upper limb other than that directly related to hemiparesis

-   hypersensitivity to Lycra

N total at baseline: 16

Important prognostic factors2:

For example

age ± SD: 65 ± 14

Sex: 68,8% M

Groups comparable at baseline?

Yes (cross over study)

Evaluation at baseline

Arm garment during 3 hours

Evaluation after 3 hour period

Cross over

Evaluation at baseline

No arm garment during 3 hours

Evaluation after 3 hour period

Cross over

Length of follow-up:

Study was performed on two different days.

Loss-to-follow-up: 0

Incomplete outcome data: 0

Outcome measures and effect size:

Spasticity (Tardieu scale)

Shoulder, vertical and horizontal adductor and internal

rotator muscles: no change between intervention and control group.

Elbow: flexors, extensors, pronators: no difference between control and intervention.

Wrist and finger flexors: significant improvement in intervention group.

AROM:

There were no differences between intervention and control for shoulder elbow and wrist. Only flexion of digit III was improved in control group.

PROM:

Significant improvement of shoulder movements

I: increase range of 4.1° ± 13° C: decline of 1.5° ± 10.7°

(p < 0.009, t test, data not shown).

No differences in elbow, fingers and wrist movement.

Garment was well tolerated

Most original data not shown. The shown data had very wide confidence intervals (e.g. PROM).

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Beckerman 1996

Type of study:

RCT

(2x2 factorial design)

Setting:

Multi centre trial

Country:

The Netherlands

Source of funding:

Not reported if there was funding for the study.

Inclusion criteria:

-   Stroke patients with walking problems caused by a spastic

 equinus or equinovatus position of the foot

-   Age 18 - 75 years

-   suffered a first ischemic or hemorrhagic stroke of a cerebral

 hemisphere resulting in hemiplegia at least 4 months before enrolment.

-   Sufficient communication and

 cognition abilities

-   satisfactory general condition

“wash-out” period of at

least 3 months was required if patients had been treated with

phenol prior to participation.

Before randomization, each patient received a nerve block

with a local anesthetic (bupivacainechloride 0.5%). Intended especially to diagnose those patients whose standing and walking ability was largely dependent on extensor spasticity.

In five patients this diagnostic nerve block had a temporary disabling effect on standing or walking; they were excluded from the trial.

Exclusion criteria:

-   more than one

 stroke

-   brain stem infarction

-   unable to walk independently;

-   neurologic, orthopedic, or vascular disorders negatively influencing

ambulatory activities.

-   structural shortening of the soleus muscle and/or gastrocnemius

muscle

-   skin lesions or foot deformities since they preclude

the proper fitting of an AFO.

N total at baseline: 60

Intervention:

1. 15
2. 16
3. 15

Control:

1. 14

Important prognostic factors:

For example age (range):

Intervention:

1. 58 (21-71)
2. 55.5 (33-69)
3. 58 (26-66)

Control:

1. 58 (21-72)

Sex:

Intervention:

1. 80 % M
2. 81,3%M
3. 53,3%M

Control:

1. 71,4 % M

Post stroke time months (range)

Intervention:

1. 34 (5-64)
2. 39.5 (5-143)
3. 47 (12-154)

Control:

1. 24.5 (9-185)

Groups comparable at baseline?

Group 4, the double-placebo group,

had the highest median age (60.5 years) and the shortest median

period poststroke (2 years), and more left-sided than right-sided

hemiplegic subjects, but at baseline also had poorer scores on

the outcome measures

1. TH + AFO

2. PTH +AFO

3. TH + PAFO

Thermocoagulation(TH) of the tibial nerve. After anesthetizing the skin, a needle was placed into the tibia nerve. With low frequency stimulation, the nerve fibers innervating the spastic muscles that most hampered the patient’s gait (cg,

soleus muscle, gastrocnemius muscle, tibial posterior muscle,

or toe flexors) were further localized and anesthetized (5 cc

lidocainechloride 2%). Subsequently, these fibers were heatinjured

with radiofrequency energy (3OOkHz. Model RFG 3b

Lesion Generator”). The temperature was brought to 80°C within

40 seconds and was held constant for the next 60 seconds.

This procedure was repeated twice after a slight change of position of the needle within the nerve. This treatment protocol has already been proven clinically useful.”

The second treatment

condition consisted of placebo thermocoagulation (PTH). The

treatment protocol was similar, including the anesthetizing of

the tibial nerve; however, radiofrequency energy output was zero.

4.PTH + PAFO

A polypropylene AFO

was custom-made for each patient. The AFO under investigation

consisted of a polypropylene AFO in 5” dorsiflexion, corrected

for shoe heel height. This AFO has been designed to prevent

an cquinus or equinovarus position of the foot during walking

and inhibit the synergistic extension pattern.“’ During the stance

phase only a minimal dorsiflexion is possible, caused by the

transformation of the material. On the contrary, plantar flexion

is impossible.

The placebo AFO (PAFO) consists of a polypropylene

hinged AFO that allows normal range of motion of

dorsiflexion and plantar flexion. Varus and valgus positioning

of the foot is corrected by both AFOs.

Length of follow-up:

12 weeks

Loss-to-follow-up:

Intervention n (%, reason)

1. 0
2. 2 (12.5%, reasons unknown)
3. 0

Control:

4. 1 (7,1%, disappointing treatment results)

Incomplete outcome data:

none

Outcome measures and effect size (include 95%CI and p-value if available):

Improvement (%) on

SIP category “ambulation” after 12 weeks median (range)

1. 6.45 (-4.7 to 15.0)

2. 3.23 (-12.8 to 13.2)

3. -2.65 (-9.4 to 21.7)

4. 0.00 (-9.0 to 15.5)

There were no sign. differences between any of the groups

Improvement (%) on

SIP total score after 12 weeks.

1. 0.79 (-5.5 to17.0)
2. 2.52 (-1.9 to 10.2)
3. -1.47 (-10.1 to 9.5)
4. 1.02 (-9.9 to 8.1)

There were no sign. differences between any of the groups

Adverse effects:

Thermalccoagulation:

Local problem due to injection (n=4)

Neurological problems

Sympathetic dystrophy (n=1)

Extended neuralgia (n=1 TH and n=1 PTH)

Orthose:

Problems related to range of motion, walking, proper fitting of the shoes with the orthose or proper fitting of the prthose itself, handling the material of the orthose. No specific data available.

Both thermocoagulation and ankle foot orthese (12 weeks) are not beneficial in improving the walking ability measured with the SIP.

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Cakar 2010

Type of study:

cross over trial

Setting:

Single centre, tertiary hospital.

Country:

Turkey

Source of funding:

No funding reported.

Inclusion criteria:

-   Ashworth grade 1 or 2 spasticity at affected calf muscles

-   Brunnstrom motor recovery stage 2 or 3

-   Able to walk independently without an assistive device

Exclusion criteria:

-   Cognitive impairment (mini mental test score < 24)

-   Visual defects of clinical importance

-   Hemineglect

-   Severe heart failure and co-morbidities that would affect mobility (severe arthrosis, rheumatoid arthritis, back problems)

N total at baseline: 25 (cross over)

Intervention: 25

Control: 25

Important prognostic factors:

For example age ± SD:

60.52 ± 11.43

Sex: 68% M

Mean post stroke duration (months)

20.32 ± 1.65

Groups comparable at baseline?

Yes, since it’s a cross over design.

Patients were provided with a well fitted prefabricated AFO and instructed to to wear the garment for during all walking activities the week before testing.

It’s a cross over design. All patients were assessed without AFO and after 15 minutes rest tested again with AFO.

Berg balance scale (Berg) , postural stability test and fall risk test of Biodex balance system (BBS) with AFO

Berg balance scale (Berg), postural stability test and fall risk test of Biodex balance system (BBS)

without AFO.

Length of follow-up:

One day testing

Loss-to-follow-up: 0

Incomplete outcome data: 0

Outcome measures and effect size (include 95%CI and p-value if available):

Berg balance scale (Berg)

I: 47.52 ±7.77

C: 42.12 ± 9.05

P=0.001

Measured with Biodex balance system (BBS:

Postural stability test (overall stability)

I: 3.09 ± 1.58

C: 3.10 ± 1.87

P = 0.96

Fall risk test

(Overall stability index)

I: 2.69 ± 1.65

C: 3.35 ± 1.97

P=0.001

Patients were traind 1 minute for adaptation to the machine (BBS) in order to reduce any learning effects.

Significant improvement on Berg balance scale and fall risk test in favour of AFO.

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Gatti 2012

Type of study:

Controlled trial

Setting:

Not reported

Country:

Argentina

Source of funding:

None

Inclusion criteria:

Exclusion criteria:

N total at baseline: 10

Intervention: 10

Control: 10

Important prognostic factors2:

For example

age ± SD:

I:

C:

Sex:

I: % M

C: % M

Groups comparable at baseline?

3 times walking 2 steps with AFO

3 times walking 2 steps without AFO

Length of follow-up:

Loss-to-follow-up:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

Knee flexion angle

Abbreviations:

RCT: randomized controlled trial

MAS: Modified Ashworth Scale (0-4)

BTA: Botuline toxine A

IU: units

ADL: activities of daily living

ESS: European Stroke Scale

MTS: Modified Tardieu Scale of Muscle Spasticity

DAS: disability assessment scale (0-3)

TH: Thermocoagulation

AFO: ankle foot orthosis

PTHO: Placebo Thermocoagulation

PAFO: Placebo Ankle Foot Orthosis

SIP: sickness Impact Profile

BBS: biodex balance system

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Carda 2011

Computer generated

Unclear

Likely

Likely

Unlikely

Unlikely

Unclear

Unlikely

Farina 2008

Not described

Unclear

Likely

Likely

Unlikely

Unlikely

Unlikely

Unlikely

Copley 2013

Random number table, generated by an independent researcher

Unlikely

Likely

Likely

Unlikely

Unlikely

Unlikely

Santamato 2015

Computer generated

Unclear

Likely

Unlikely

Unlikely

Unlikely

Unlikely

Unlikely

Gracies 2000

Not randomized, cross over study

Unlikely

Unlikely

Unlikely

Likely

Unlikely

Unlikely

Beckerman 1996

Prepared by an independent statistican using random permuted blocks

Unlikely

Unlikely²

Unlikely³

Unlikely

Unlikely

Unlikely

Unlikely

Cakar 2010

Not randomized, cross over study

Unlikely

Likely⁴

Unlikely

Likely

Unlikely

Unlikely

Unlikely