Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Anjum, 2016

Type of study:

RCT

Setting and country:

Artificial Limb Centre of Fauji Foundation Hospital, Pakistan

Funding and conflicts of interest:

Not reported

Inclusion criteria:

-unilateral transtibial amputation

-lack of contracture

-first time or old prosthetic user

-one third stump length

Exclusion criteria:

Wet wounds, phantom pain, neuroma, swelling, contractures

bilateral lower extremity amputations

N total at baseline:

Intervention n=31

Control n=32

Important prognostic factors:

No patient characteristics reported

Groups comparable at baseline?

proprioceptive neuromuscular facilitation (PNF) techniques

The PNF group underwent 30 minutes session of weight bearing, weight shifting, balance exercise, single limb loading, and stepping. The PNF principal (e.g. manual contact, verbal command, vision, and timing for emphasis, resistance, approximation, stretch, slow reversal, and rhythmic stabilization) were

applied

traditional prosthetic strength training (TPT)

30 minutes session of weight bearing, weight shifting, balance exercise, single limb loading, stepping, and strength training through sand bag

Length of follow-up:

4 weeks

Loss-to-follow-up:

-

Incomplete outcome data:

-

Locomotor capabilities index

Mean (sd)

I: 23.93 (4.24)

C: 18.18 (7.78)

p < 0.001.

Sahay,

2014

Type of study:

RCT

Setting and country:

India

Funding and conflicts of interest:

Not reported

Inclusion criteria:

-lack of muscle contractures

or lack of limitations in the joint range of motion;

-absence of other limb segments;

-first-time prosthetic user;

-minimum stump length of one-third of the tibial length.

Exclusion criteria:

-history of vascular

disease,

-hypertension, phantom pain, neuroma, cardiac

disease,

-gross deformities of stump such as tightness,

contracture, or deformity (more than 5 degrees of malalignment).

N total at baseline:

N= 30

PNF: 15

TPT: 15

Important prognostic factors:

Age (year, sd)

I: 40.27 (5.08)

C: 38.40 (5.73)

Sex (men/women) I: 10/05

C: 09/06

Groups comparable at baseline?

Yes

PNF: 2 weeks of preprosthetic phase training and prosthetic phase training & proprioceptive

neuromuscular facilitation (PNF)

Preprosthetic phase (week 1) included strengthening of the lower limbs.

Prosthetic phase (week 2) included 30 min muscle strengthening, weight

bearing, weight shifting, balance exercises and gait

training.

All aforementioned

trainings were based on PNF principles and techniques. The four main techniques were resistance, approximation, slow reversal, and rhythmic stabilisation

TPT: Traditional prosthetic training consisting of a preprosthetic phase and a prosthetic phase.

Preprosthetic phase consisted of muscle strengthening exercises.

Prosthetic phase consisted of weight bearing on the prosthetic limb, weight shifting, balance exercises, and gait training.

Length of follow-up:

2 weeks

Loss-to-follow-up:

-

Incomplete outcome data:

-

Locomotor Capabilities Index; LCI

I: mean (sd)

Pre: 40.3 (3.8)

Post: 47.9 (4.0)

C: mean (sd)

Pre: 38.6 (3.4)

Post: 43.7 (3.0)

P=0.006

Stride width (cm)

I: mean (sd)

Pre: 14.5 (2.9)

Post: 11.0 (1.8)

C: mean (sd)

Pre: 15.1 (3.0)

Post: 12.9 (2.4)

P=0.025*between-group difference, based on the independent t test post-test

Pauley, 2014

Type of study:

Single-blind, cross-over (AB/BA) trial with randomization.

Setting and country:

West Park Healthcare Centre and

St. John’s Rehabilitation Hospital, Canada

Funding and conflict of interest:

This project was funded by a research grant provided by the Canadian

Diabetes Association.

Inclusion criteria:

-unilateral, TFA secondary to diabetes or peripheral

vascular disease,

=>65 years or older,

-6-months post-fitting with

a prosthesis,

-ambulatory prosthetic users,

-able to complete all testing procedures,

Exclusion criteria:

-taking medications that may impair balance,

-involved in a concurrent exercise program

N total at baseline:

N= 17

EC: 9

CE: 8

Important prognostic factors:

Gender, male, n (%) 13 (76)

Age, mean (SD) 67.8 (5.2)

Time since amputation, years

mean (SD)

7.3 (8.2)

Comparable at baseline

? Baseline characteristics not reported for I & C separately

Hip abductor resistance training (experimental treatment), twice weekly supervised training sessions for 8 weeks.

Arm ergometry (control treatment)

Control subjects underwent supervised arm ergometry training twice weekly for 8 weeks.

Length of follow-up:

2 periods of 8 weeks, with an 8-week washout period

Loss-to-follow-up:

I: n=1

C: n=1

Incomplete outcome data:

I: n=1

C: n=1

Both opted not to transition to the period 2 treatment upon completion of the period 1 treatment due to personal reasons.

The Timed Up & Go (TUG) test

Hip abductor training resulted in 17% faster TUG time (24.6 s (SD 11.4) versus. 29.6 s (SD 14.6),

p < 0.01),

Effect size (d)

TUG, s

Intervention

Pre: I: 31.3 (13.4)

Post: 24.6 (11.4)

P<0.01

Control

Pre: C: 30.0 (14.3)

post: 29.6 (14.6)

2 Minute Walk (2MW),

7% greater 2MW distance I :60.9 m (SD 18.2) versus. C: 56.8 m (SD 17.3), p < 0.05)

2MW, m

Intervention

Pre: 54.0 (15.9)

Post: 60.9 (18.2)

P<0.05

Control

Pre: 57.1 (17.9

Post: 56.8 (17.3)

Nolan,

2012

Type of study:

RCT

Setting and country:

Sweden

Funding and conflicts of interest:

The study received financial support from Allmäna

arvsfonden, CIF (Centre for Sport Research, Stockholm) and GIH,

Stockholm.

Inclusion criteria:

-Lower limb amputation

Exclusion criteria:

-

N total at baseline:

N= 16

I: 8

C: 8

Important prognostic factors:

Age (years)

I: 41.1

C: 49

–Trauma, tumor,

congenital

–TT, TF

LLA (years as amputee)

EG: 8.2 ± 9.2

CG: 8.3 ± 11.3

Groups comparable at baseline?

Yes

EG: Hip strengthening

program

10 weeks, 2 supervised sessions p/w. Training consisted of warm-up, balance and co-ordination exercises, hip strengthening

exercises and a cool-down for each session. The warm-up consisted of 20 min stationary bicycle. Balance and co-ordination exercises: balancing on an unstable surface, stepping over obstacles, sit-ups and push-ups, walking along a narrow line on the floor placing one foot in front of the other, walking through a series of small hoops placed flat on the floor with one footstep in each hoop until the end of the series, or standing on one leg and touching each of 3 separate markers on the floor with the other foot, then changing stance foot. The hip strengthening exercises included “slow” hip flexion and extension and “fast” hip flexion and extension. All movements were performed with an ankle weight

CG: Usual activities

Length of follow-up:

10 weeks

Loss-to-follow-up:

-

Incomplete outcome data:

-

–Oxygen consumption

while walking at 1.0

m/s monitored using an

Oxycon-Pro

Figure 5

Significant decrease in Intervention group versus no significant decrease in control group

–Running ability

(defined as min 10s leg-over-leg running on a treadmill:

I: n=6

C: n=0

Rau,

2007

Type of study:

Randomized

controlled trial

Setting and country: clinical setting,

Myanmar

Funding and conflicts of interest:

Not reported

Inclusion criteria:

> 15 years of age,

-suffered from a traumatic or

tumor related cause of amputation,

-unilateral trans-femoral, knee-disarticulation, transtibial,

ankle disarticulation or partial foot amputations,

-never been fitted or had already

one or more prosthetic device

-good general condition.

Exclusion criteria:

-bilateral and hip disarticulation amputation,

-congenital deformation,

-impossibility to stay for 5 days post-fitting training,

-bad stump

condition (e.g. sores or important contractures not allowing fitting),

-cognitive limitations,

-major cardiopulmonary affections

-no oral informed consent

N total at baseline:

I: 29

C: 29

Important prognostic factors:

Age:

I: 36.93 years

C: 35.24 years

Time since amputation (years)

I: 11.3 (8)

C: 9.6 (5)

–Trauma, tumour

–TF, TT, KD, AD,

PAR

–Subjects above

15 years of age

–Had never been

fitted or had

already one or

more prosthetic

device

Groups comparable at baseline?

yes

EG: Functional gait training This specific training

included lower-limb

strengthening exercises,

weight-bearing,

coordination tasks, corrected

walking, obstacle

management, functional

training.

progressive weight bearing exercises

CG: usual care which consisted mainly of walking under

supervision

Length of follow-up:

3 months

Loss-to-follow-up:

-

Incomplete outcome data:

-

−2MWT, 2-minute walk test

–PCI, MacGregor

Physiological Cost Index

–Q-FMA (5 questions) Functional Measure for Amputees Questionnaire

–TUG Timed Up and Go test

Gait speed

%change

EG: 12.7

CG: 0.17

P= 0.016

Mean (m/s):

EG: 4.9

CG: 0.07

P= 0.016

LCI-score (0-42)

1.90 (4.42)

2.00 (4.68)

p= 0.930

PCI

(beats/m)

(heart rate at the end (beats/min) – heart rate at rest (beats/min))/speed (m/min)

Baseline PCI score:

I: 0.189 (0.135)

C: 0.290 (0.317)

Mean improvement (beats/m)

I: 0.77

C: 0.39

P=-002

Trauma landmine victims

The majority had never

received any kind of rehabilitation.

Yigiter, 2002

Type of study:

RCT

Setting and country:

Department of Prosthetics and Biomechanics, School of Physical Therapy and Rehabilitation,

Hacettepe University, Ankara, Turkey.

Funding and conflicts of interest:

Not reported

Inclusion criteria:

- unilateral trans-femoral amputees

Exclusion criteria:

-muscle weakness other than weakness related to the level of amputation.

-muscle shortening, joint motion limitations or

other problems preventing weight bearing and walking

N total at baseline:

N= 50

I: n=25

C: n=25

Important prognostic factors:

Age, years

Mean (sd)

I: 28.16 (7.24)

C: 28.18 (6.48)

Sex (%M)

100%

Time since amputation, months

Mean (sd)

7.20 (0.76)

Groups comparable at baseline?

yes

PNF proprioceptive

neuromuscular facilitation (PNF) 30 min/d ×10 sessions

In the PNF group, in addition to free dynamic

balance exercises static balance exercises were

given. Also in the PNF group approximation was

applied to restore the relationship between the

prosthetic foot and the group.

Traditional training

TPT group,

traditional prosthetic training consisting of

weight-shifting, dynamic balancing activities,

stool stepping, braiding, gait exercises and climbing/descending the stairs

Length of follow-up:

Not reported

Loss-to-follow-up:

-

Incomplete outcome data:

-

Gait speed

Velocity difference, cm/s (sd),

%change

I: 14.72 (3.81) (28.6%)

C: 9.6 (3.6) (18.4%)

Step width (cm, sd)

Intervention

Pre: 18.72 (1.05)

Post: 13.92 (3.37)

Control

Pre: 19.08 (2.00)

Post: 16.48 (2.31)

P<0.05 post-test

Male traumatic amputees and were in the prosthetic

phase of rehabilitation for their first prosthesis. The mean time elapsed since amputation was 7.20 ± 0.76 months

All subjects received postoperative and preprosthetic

physiotherapy procedures including stump

positioning, bandaging, stretching and dynamic exercises, balancing activities in parallel bars and

finally three-point ambulation.

Schafer, 2018

Type of study:

RCT

Setting and country:

Local prosthetics centers, UK

Funding and conflicts of interest:

“The authors declare that there are no conflicts of interest.”

Inclusion criteria:

-unilateral transtibial or transfemoral amputation for any reason

-prosthesis use daily

-able to ambulate independently along level surfaces with or without mobility aids

Exclusion criteria:

-any chronic diseases, cardiac complications, uncontrolled asthma or diabetes, severe osteoporosis, or cognitive disorders

-currently engaged in structured exercise programmes

N total at baseline

N=15

Intervention n=7

Control n=8

Important prognostic factors:

Time since amputation

Years (sd)

I: 10 (17)

C: 19 (20)

Groups comparable at baseline?

yes

Exercise intervention

12-week supported exercise

intervention. Participants attended a supervised, circuit-style group

exercise session twice weekly at the University, and completed personalised

exercises at home once a week, progressing to twice-weekly from the mid-point of the intervention.

Group and home exercises were multi-dimensional and designed to target gait endurance and speed

(beyond their comfortable), flexibility (e.g., dynamic and static stretching of major muscle groups), strength (e.g., concentric/eccentric

dynamic exercises such as squats, sit-ups, step-ups, calf raises, hip abduction,

– with optional use of therabands, kettlebells or dumbbells), dynamic balance (e.g., picking up objects from the floor and balancing on a compliant surface) and cardiovascular fitness (cycle ergometer).

Control? Usual care?

Follow-up:

12 months

Loss-to-follow=up

I n=2

1 health reasons

1 attrition

C: n=2

1 health reasons, 1 attrition

Falls (defined as inadvertently coming to rest on the ground or other lower level)

I: n, mean (sd)

Baseline: 6.1 (7.4)

12 months: 0.1 (0.4)

C: mean (sd)

Baseline: 1.4 (1.2)

12 months: 4.0 (4.8)

“the exercise group also recorded significantly fewer falls than the control group during the 12-month follow-up period (F(1,13)=5.1; 95% CI=−7.5, −0.2; P=0.041),

with a significant group*time interaction (F(1,13)=7.9; P=0.015).”

Walking speed (m/s)

I: mean (sd)

Pre 0.77 (0.25)

Post 0.98 (0.21)

C: mean (sd)

Pre 0.84 (0.31)

Post 0.82 (0.28)

(P<0.05)

Gait speed in the exercise group increased by 0.21

(P < 0.001; d=0.91),

significant group*time interactions for speed (F(1,13)=15.8; P=0.002) due to improvements in the exercise group, but no observed change in the control group.

 All participants had sustained a fall in the 2-year period prior to study enrolment, or were deemed at-risk by their multidisciplinary

healthcare team.

Imam,

2017

Type of study:

randomized controlled feasibility trial.

Setting and country:

GF Strong Rehabilitation

Centre in Vancouver BC Canada.

Funding and conflict of interest:

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication

of this article.

Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of

this article: This trial was funded by Amputee Coalition of Canada and the University of Alberta-Franklin Fund. Bita Imam is a Vanier Canada Graduate Scholar. Janice J

Eng is a Michael Smith Foundation Scholar.

Inclusion

criteria:

-community-living

-⩾ 50 years of age,

-⩾ 1-year post a

unilateral transtibial or transfemoral amputation;

-using a prosthesis for at least 2 hours/day (past 6 months)

-currently not participating

in formal exercise/training program.

Exclusion criteria:

-inability to provide consent or to

communicate in English

-substantial medical conditions contraindicating participation in exercise program

-prosthetic socket fit issues (scores <6 on the Prosthetic Socket Fit Scale)

N total at baseline:

N=24

I: n=12

C: n=12

Important prognostic factors:

Median (range) age: 62.0 (50-78) years.

Years since amp, median (range)

I: 9.0 (1.0–56.4)

C: 11.0 (2.0–40.7)

Total: 10.8 (1.0–56.0)

Groups comparable at baseline?

Yes

Intervention:

Wii.n.Walk consisted of Wii Fit training, 3x/week (40-minute sessions), for 4 weeks. Training started in the clinic in groups of 3 and graduated to unsupervised home training.

Control group participants were trained using cognitive games.

Length of follow-up:

3 weeks

Loss-to-follow-up:

Intervention:

N (%) =1

Reasons (describe)

Complications due to pre-existing lung disease

Control:

N (%) = 0

Incomplete outcome data:

-

Primary clinical outcome: walking capacity (2MWT) baseline, end of

treatment, and 3-week retention.

2MWT (meters)

I: mean (SD); 95%CI

Baseline 141.1 (44.0)

T1: 146.3 (44.5);

(121.1,171.5)

T2: 148.5 (47.4);

(120.5, 176.5)

C: mean (SD); 95%CI

Baseline: 133.3 (43.5)

T1: 131.9 (41.5);

(108.4,155.4)

T2: 133.3 (42.0);

(109.5, 157.1)

F:

T1: 1.8

T2: 2.5

Cohens d:

T1: 0.5

T2: 0.6

Feasibility trial: the required sample size for a future larger RCT was deemed to be 72 (36 per arm).

Feasibility indicators: trial process (recruitment, retention, participants’ perceived benefit

from the Wii.n.Walk intervention measured by exit questionnaire), resources (adherence), management

(participant processing,

blinding), and treatment (adverse event, and Cohen’s d effect size and variance).

Mean (SD) score for perceived benefit from the Wii.n.Walk intervention was 38.9/45 (6.8).

Adherence was 83.4%.

Study reference

(first author, publication year)

Describe method of randomisation

Bias due to inadequate concealment of allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?

(unlikely/likely/unclear)

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

(unlikely/likely/unclear)

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

(unlikely/likely/unclear)

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

(unlikely/likely/unclear)

Bias due to loss to follow-up?

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?

(unlikely/likely/unclear)

Anjum, 2016

“Patients were randomly divided into PNF group (n=31) and traditional strength training group (n=32).”

Unclear

Likely

Likely

Likely

unlikely

Unlikely

Unlikely

Imam, 2017

This was a parallel, evaluator-blind RCT. Participants were block randomized using a 1:1 ratio by a biostatistician to either the Wii.n.Walk or control intervention using a computerized randomization

process with variable block sizes.

Unlikely

Likely

Unlikely

Unlikely,

allocation was concealed

until baseline measurements were completed.

Unlikely

Unlikely

Unlikely

Nolan, 2012

Prior to pre-testing,

the participants were divided into two groups, as matched as possible based primarily on gender, amputation level and years as an amputee

Unclear

Likely

unlikely

Unclear

unlikely

unlikely

Unlikely

Pauley, 2014

“This study utilized a single-blind (evaluator), cross-over trial (AB/

BA) with randomization. Subjects were randomised using the random numbers generator function in Microsoft Excel (i.e., = R AND()) by the study Principal Investigator who was not involved in data collection

or subject orientation/ supervision. Group assignment was

conducted by the study Research Assistant.”

unlikely

likely

unlikely

unlikely

unlikely

Unlikely

Unlikely

Rau, 2007

In this randomised controlled trial (RCT), a randomisation list was generated by computer,

with block size of four and provided by the department of epidemiology, Maastricht

University. Allocation was concealed.

unlikely

Likely

Blinding of the

patients was for obvious reasons impossible.

unlikely

Likely

Because of existing constraints (e.g. limited human resources or lack of experienced national staff), blinding of the assessors was not feasible.

unlikely

unlikely

Unlikely

Sahay, 2014

“The study participants were first screened in accordance with the inclusion and exclusion criteria. They were then allocated by computer-generated randomisation to the PNF group or the traditional prosthetic training (TPT) group.”

Unlikely

Likely

likely

unclear

unlikely

unlikely

Unlikely

Schafer, 2018

“Participants were block randomised according to age and level of’ amputation (exercise, n=7; control, n=8) by an independent researcher, following baseline assessments.”

unlikely

Likely

likely

unclear

unlikely

unlikely

unlikely

Yigiter, 2002

“They were randomly assigned into groups receiving PNF (PNF Group) and traditional prosthetic training (TPT Group).”

unclear

likely

likely

unclear

unlikely

unlikely

Unlikely