Hull Early Walking Aids for Transtibial Amputees - Randomised Control Trial (HEART)

Study Overview
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Brief Summary
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Early walking aids are routinely used in UK for rehabilitation of patients with below knee amputations. The two main walking aids used commonly in practice include the non-articulated Pneumatic Post Amputation Mobility Aid (PPAM)and the Articulated Amputee Mobility Aid (AMA). There is no published evidence on whether the articulated walking aid improves knee control and shortens delivery time. This study was designed to test the hypothesis that an articulated early walking aid has benefit to transtibial amputee compared to non-articulated early walking aid.

Detailed Description
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Physiotherapists in the UK routinely use Early Walking Aids (EWA's) to enable the lower limb amputee to start to walk again as early as 5 days post amputation (Lein S. 1992). An EWA has many benefits including a reduction in oedema (Reith et al, 1992) early gait and balance training in preparation for using a prosthesis. The two EWA's most commonly used in the UK for transtibial amputees are the Pneumatic Post Amputation Mobility aid (PPAM) and the Amputee Mobility Aid (AMA). A comparison of the PPAM aid and the AMA undertaken by Longmore T (1997) reported no significant difference in energy cost, comfort or ease of use. Scott et al (2000) found the AMA to have higher interface pressures than the PPAM aid. There is however no known published evidence on whether an articulated EWA improves active knee control following prosthetic delivery and therefore shortens rehabilitation time. In addition there is no known published evidence of the effect on quality of life with the two different EWA's. Hypothesis: An articulated Early walking aid has benefit to the transtibial amputee compared to a non- articulated EWA. The purpose of this proposed research is to investigate whether there are any benefits to patients in using an articulated EWA. The study will use EMG and gait analysis to determine the potential of each of the two EWA's to re-educate gait in a way that is comparable with the gait exhibited when the subject subsequently begins to use a prosthesis thus shortening rehabilitation time. Quality of life indicators will be used to determine the impact on the patient and, in addition, the length of time taken to full rehabilitation will be considered.

Official Title
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Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial

Conditions
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Unilateral Trans-tibial Amputees

Intervention / Treatment
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* Device: EWA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included in the trial if they: Have had a unilateral transtibial amputation but not yet received a prosthesis Are expected to receive a functional prosthesis Are at least 18 years of age Are able to tolerate and use an early walking aid Are able to be able to walk a distance of 4 metres Will attend Hull and East Yorkshire Hospitals NHS Trust for prosthetic rehabilitation. Meet the manufacturers recommendations for using the EWA's Exclusion Criteria: Patients will be excluded from the trial if they: Have had a major amputation of the contra lateral limb. Are not expected to receive a functional prosthesis Were unable to walk, prior to their amputation, due to a medical condition e.g. spinal injury, stroke or rheumatoid arthritis Are unable to follow instructions and/or participate in a programme of rehabilitation. Do not consent to participate in the study. Do not meet the manufacturers recommendations for using the EWA's

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPAM Aid<br>Suitable participants randomised to the treatment arm will receive the non articulated pneumatic early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. | Device: EWA<br>* Suitable participants randomised to the treatment arm to receive early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed.<br>* Other names: Amputee Mobility Aid - Ortho Europe Ltd,UK;|
| Active Comparator: AMA Aid<br>Suitable participants randomised to the treatment arm will receive the articulated early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed. | Device: EWA<br>* Suitable participants randomised to the treatment arm to receive early walking aid and rehabilitation physiotherapy will be commenced immediately. Physiotherapy will continue after they receive their definitive prosthesis till they are comfortable and safe using it, at which stage they will be discharged and no further follow up will be performed.<br>* Other names: Amputee Mobility Aid - Ortho Europe Ltd,UK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic and kinematic comparison of the influence of 2 different EWAs on the transfer to prosthetic rehabilitation. |  | Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measurements |  | Outcomes will be measured at baseline, time of EWA fitting, prosthesis fitting, 2 week post prosthesis fitting &on discharge from physiotherapy ensuring safe prosthesis use. Final visit will vary with each patient and will be analysed with outcomes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Walking Aid, Amputee, Trans-tibial, Quality of life