Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2022-05-01

Brief Summary

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Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.

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Detailed Description

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Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.

Conditions

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Amputation Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Group A

Weekly exercise sessions with physical therapist and psychologist

Group Type EXPERIMENTAL

Weekly exercise sessions with physical therapist and psychologist

Intervention Type BEHAVIORAL

Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.

Exercise Group B

Home-based exercises

Group Type PLACEBO_COMPARATOR

Home-based exercises

Intervention Type BEHAVIORAL

Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress.

Interventions

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Weekly exercise sessions with physical therapist and psychologist

Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.

Intervention Type BEHAVIORAL

Home-based exercises

Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age ≥18 years
* unilateral lower limb amputation without serious complications
* at least 6 months experience using a definitive lower limb prosthesis
* Activity Specific Balance Confidence (ABC) scale score≤80
* self-reported concern about balance that limit activities

Exclusion Criteria

* active wounds on weight bearing surfaces
* inability to perform the protocol without an assistive device
* currently seeing a physical therapist for any reason
* history of neurodegenerative disease
* history of stroke
* ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
* prohibited by primary care physician or research physician to participate in mild exercise

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No