An interventional study of Weekly exercise sessions with physical therapist and psychologist and Home-based exercises in Amputation and Physical Activity, sponsored by Rosalind Franklin University of Medicine and Science. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and Treatment
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Rosalind Franklin University of Medicine and Science is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Weekly exercise sessions with physical therapist and psychologist
Behavioral: Weekly exercise sessions with physical therapist and psychologist
Home-based exercises
Behavioral: Home-based exercises
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.
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.
Community integration
number of steps taken outside of the home
Time frame: 24 weeks
Social Functioning scale from the 36-item Short Form Health Survey
The scale measures the extent to which physical and emotional problems interfere with social activities on a scale of 0-100 with higher scores indicating less interference
Time frame: 24 weeks
Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
The scale measures the extent to which emotional problems interfere with work and daily activities on a scale of 0-100 with higher scores indicating less interference
Time frame: 24 weeks
Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
The scale measures community participation in terms of how often an individual engages in certain activities on a score of 10-70 with higher scores indicating greater participation
Time frame: 24 weeks
Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
Time frame: 24 weeks
Frenchay Activity Index
This is a behavioral scale that primarily measures social participation, as well as daily activities on a score of 0-45 with higher scores indicating greater social activity.
Time frame: 24 weeks
Change from baseline in Activity-specific balance confidence scale following the intervention
The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
Time frame: 8 weeks
Activity-specific balance confidence scale
The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence. Measurement at this time point will indicate the lasting impact of the intervention on balance confidence
Time frame: 24 weeks
Well-being scale from the Prosthetic Evaluation Questionnaire
The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.
Time frame: 24 weeks
Change from baseline in Berg Balance Scale
This scale measures measures balance function by assessing the performance of functional tasks. It is scored from 0-45 with high scores indicating better balance.
Time frame: 8 wks
Change from baseline on L-test performance
Participants rise from a chair without armrests, walk 3m, turn right, walk 7m, turn around and trace their path back to the start. Time to complete the task is noted.
Time frame: 8 wks
Ran from Apr 2018 to primary completion in May 2022, 48 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 48 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Rosalind Franklin University of Medicine and Science