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Targeting Balance Confidence to Increase Community Integration in Users of Prostheses

Rosalind Franklin University of Medicine and Science logo

Rosalind Franklin University of Medicine and Science

Status

Completed

Conditions

Physical Activity
Amputation

Treatments

Behavioral: Home-based exercises
Behavioral: Weekly exercise sessions with physical therapist and psychologist

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03411148
W81XWH-17-1-0697 (Other Grant/Funding Number)
OP160044

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups, including a placebo group

Exercise Group A
Experimental group
Description:
Weekly exercise sessions with physical therapist and psychologist
Treatment:
Behavioral: Weekly exercise sessions with physical therapist and psychologist
Exercise Group B
Placebo Comparator group
Description:
Home-based exercises
Treatment:
Behavioral: Home-based exercises

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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