Hull Early Walking Aids for Transtibial Amputees - Randomised Control Trial (HEART) (HEART)
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| ClinicalTrials.gov Identifier: NCT01024023 |
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Recruitment Status : Unknown
Verified December 2009 by University of Hull.
Recruitment status was: Active, not recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Unilateral Trans-tibial Amputees | Device: EWA | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | Hull - Early Walking Aids for Transtibial Amputees - Does an Articulated Knee Have Benefits? A Randomised Controlled Trial |
| Study Start Date : | December 2004 |
| Estimated Primary Completion Date : | December 2009 |
| Estimated Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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- 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. ]
- 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. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024023
| United Kingdom | |
| 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, HU3 2JZ | |
| Department of Sports, Health & Exercise Science, University of Hull | |
| Hull, Humberside, United Kingdom, HU6 7RX | |
| 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 |
| Responsible Party: | Amanda Hancock / Physiotherapy Clinical Manager Inpatients CHH, Physiotherapy Department, Castle Hill Hospital, Hull & East Yorkshire Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01024023 |
| Other Study ID Numbers: |
R0081 |
| First Posted: | December 2, 2009 Key Record Dates |
| Last Update Posted: | December 2, 2009 |
| Last Verified: | December 2009 |
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Early Walking Aid Amputee Trans-tibial Quality of life |