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

December 1, 2009 updated by: University of Hull

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Humberside
      • Hull, Humberside, United Kingdom, HU3 2JZ
        • Academic Vascular Surgical Unit, University of Hull
      • Hull, Humberside, United Kingdom, HU3 2JZ
        • Physiotherapy Department, Hull & East Yorkshire Hospitals NHS Trust
      • Hull, Humberside, United Kingdom, HU6 7RX
        • Department of Sports, Health & Exercise Science, University of Hull

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PPAM Aid
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
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.
Other Names:
  • Pneumatic Post Amputation Mobility Aid - Ortho Europe Ltd,UK
  • Amputee Mobility Aid - Ortho Europe Ltd,UK
ACTIVE_COMPARATOR: AMA Aid
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
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.
Other Names:
  • Pneumatic Post Amputation Mobility Aid - Ortho Europe Ltd,UK
  • Amputee Mobility Aid - Ortho Europe Ltd,UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Kinetic and kinematic comparison of the influence of 2 different EWAs on the transfer to prosthetic rehabilitation.
Time Frame: 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.
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
Time Frame
Quality of life measurements
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hull

Collaborators

Hull University Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Amanda Hancock, MSc, Department of Physiotherapy, Hull & East Yorkshire Hospitals NHS Trust
  • Study Director: Ian C Chetter, MB ChB, FRCS, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R0081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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