Outcome Measures for Lower Limb Amputees - A Rehabilitation Study

NCT01946321 | Completed

• 1 other identifier: QMU/JS0121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

During any period of rehabilitation it is important to select meaningful tests that; measure what you want, are responsive to changes in the patient's condition and, easy to use in the clinical settings. With an amputee such tests may help make sure that rehabilitation programmes and the prosthesis (artificial leg) provided are tailored for the individual. New prosthetic technology is continually being developed and the active amputee now demands more from their artificial limbs. Making sure that they get the right rehabilitation programmes and the most appropriate prosthesis will help them perform to their best. Thirty amputees who have recently undergone a lower limb amputation will be recruited into this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure different aspects of their recovery from the comfort of the socket to their perceived ability to undertake everyday tasks. Each of the tests give a score or grade which represents the level of their ability, as judged by the test, at that given time point. The tests will be repeated at one and three weeks after delivery of their prosthesis, just before discharge from hospital and at 6 weeks post-discharge. By measuring the changes in the scores across these time points, and also how the amputees feel they have changed, it is hoped that it can be determined how responsive the tests are to objective measures of changes in the amputees abilities and also whether the tests are sensitive to the changes felt by the amputee. If it is shown we can more accurately link changes in the scores to the changes in the amputees abilities then Physiotherapy treatment programmes could be more accurately tailored to the individual amputee.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (1)

• The changes in scores in all tests during early rehabilitation period.

  The changes in scores in all Outcome Measures during Time Period 1 and Time Period 3 will be recorded. For each Outcome Measure during each time interval the effect size (ES)will be calculated, using the formula below. These will serve as a statistical description of the sensitivity to change or responsiveness of each Outcome Measure. ES = mean diff (SV1-SV2) / (SD SV1-SV2) A higher ES value indicates higher responsiveness.

  2 weeks and 6 weeks

Secondary Outcomes (1)

• Mean scores and the score changes recorded in the two time periods under investigation, i.e. T1 and T3 will be compared within the different categories in the Activity Change Questionnaire.

  2 weeks and 6 weeks

Other Outcomes (1)

• Establish the minimal detectable changes (MDC) for each of the Outcome Measures

  24hrs

Study Arms (1)

Post-amputation functional rehab

OTHER

Patients will continue with their rehabilitation programme, as specified by their clinical team, following amputation. A series of functional outcome measures will be carried out at 3 or 4 time points during the first 3 months following delivery of their artificial limb.

Other: Post-amputation functional rehabilitation (normal clinical practice)

Interventions

Post-amputation functional rehabilitation (normal clinical practice) OTHER

Post-amputation functional rehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single lower limb amputees, at either trans-tibial (below-knee) or trans-femoral (above-knee) level 18 years or older Taking delivery of their first prosthesis (artificial limb)

You may not qualify if:

• Limb-fitting for transfer activities only Co-morbidities that may prevent the amputee undertaking any of the physical activities involved in the OMs, such as: severe heart disease, respiratory disease or arthritis Poor cognition, as identified by the patient's clinical team, which may prevent the patient from fully understanding the written questionnaires

Sponsors & Collaborators

• Queen Margaret University: lead

Study Sites (1)

Astley Ainslie Hospital

Edinburgh, EH9 2HL, United Kingdom

Location

Study Officials

• Marietta van der Linden, MSc, PhD

  Queen Margaret University, Edinburgh, UK

  STUDY DIRECTOR

• Judy Scopes, MPhil

  Queen Margaret University, Edinburgh, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

GB (1)