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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Hull.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01024023
First received: November 25, 2009
Last updated: December 1, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Unilateral Trans-tibial Amputees
Device: EWA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: December 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024023

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

Publications:
Responsible Party: Amanda Hancock / Physiotherapy Clinical Manager Inpatients CHH, Physiotherapy Department, Castle Hill Hospital, Hull & East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01024023     History of Changes
Other Study ID Numbers: R0081
Study First Received: November 25, 2009
Last Updated: December 1, 2009
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Hull:
Early Walking Aid
Amputee
Trans-tibial
Quality of life

ClinicalTrials.gov processed this record on April 17, 2014