Unilateral Trans-tibial Amputees Clinical Trial
— HEARTOfficial title:
Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial
Verified date | December 2009 |
Source | University of Hull |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 26 |
Est. completion date | December 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Academic Vascular Surgical Unit, University of Hull | Hull | Humberside |
United Kingdom | Department of Sports, Health & Exercise Science, University of Hull | Hull | Humberside |
United Kingdom | Physiotherapy Department, Hull & East Yorkshire Hospitals NHS Trust | Hull | Humberside |
Lead Sponsor | Collaborator |
---|---|
University of Hull | Hull and East Yorkshire Hospitals NHS Trust |
United Kingdom,
Barnett C, Vanicek N, Polman R, Hancock A, Brown B, Smith L, Chetter I. Kinematic gait adaptations in unilateral transtibial amputees during rehabilitation. Prosthet Orthot Int. 2009 Jun;33(2):135-47. doi: 10.1080/03093640902751762. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |