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

NCT ID: NCT01024023

Last Updated: 2009-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2010-12-31

Brief 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.

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.

Conditions

Unilateral Trans-tibial Amputees

Keywords

Early Walking Aid; Amputee; Trans-tibial; Quality of life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EWA

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

EWA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Pneumatic Post Amputation Mobility Aid - Ortho Europe Ltd,UK; Amputee Mobility Aid - Ortho Europe Ltd,UK

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

University of Hull

OTHER

Sponsor Role: lead

Responsible Party

Physiotherapy Department, Castle Hill Hospital, Hull & East Yorkshire Hospitals NHS Trust

Principal Investigators

Amanda Hancock, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Physiotherapy, Hull & East Yorkshire Hospitals NHS Trust

Ian C Chetter, MB ChB, FRCS

Role: STUDY_DIRECTOR

University of Hull

Locations

Academic Vascular Surgical Unit, University of Hull

Hull, Humberside, United Kingdom

Physiotherapy Department, Hull & East Yorkshire Hospitals NHS Trust

Hull, Humberside, United Kingdom

Department of Sports, Health & Exercise Science, University of Hull

Hull, Humberside, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 19367517 (View on PubMed)

Other Identifiers

R0081

Identifier Type: -

Identifier Source: org_study_id