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

NCT01024023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Unilateral Trans-tibial Amputees

Interventions

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.

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV
  • University of Hull

    lead OTHER

Principal Investigators

  • Amanda Hancock, MSc · Department of Physiotherapy, Hull & East Yorkshire Hospitals NHS Trust

  • Ian C Chetter, MB ChB, FRCS · University of Hull

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024023 on ClinicalTrials.gov