Skip to main content
Clinical Trials/NCT03196674
NCT03196674
Unknown
Not Applicable

The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma

Isabella Shvartz1 site in 1 country30 target enrollmentAugust 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture Humerus
Sponsor
Isabella Shvartz
Enrollment
30
Locations
1
Primary Endpoint
Shoulder range of motion
Last Updated
8 years ago

Overview

Brief Summary

This study will compare the effect of manipulated vs. non-manipulated feedback during the rehabilitation of individuals with disability due to stiff shoulder following multiple trauma. This will be accomplished using the state-of-the-art real-time motion capture technology.

Detailed Description

In this intervention, comparative study, 30 individuals with stiff shoulder following fracture to the proximal humerus (4 weeks to 6 months following the injury) will be treated at the Gait and Motion Laboratory at the Hadassah Medical Center in Jerusalem. Each subject will undergo a 12-session treatment (2-3 times a week, 30 minutes per session). In each session, reflective markers will be placed on the upper or lower body of the patient. Ten fast infra-red cameras will detect the movement of the patient and provide real-time feedback when obtaining a correct movement pattern, as instructed by the therapist, pretrial. The motion capture system will provide visual and auditory feedback of success, via a large screen, located on the wall. This could be manipulated so that the feedback is provided for a slightly higher range than instructed by the therapist. The subjects will be randomly divided into two groups. One group will receive the non-manipulated feedback treatment for 6 sessions and then the manipulated feedback treatment for the remaining 6 sessions and vice versa for the second group. The shoulder passive and active range of motions, pain and activity levels will be tested 3 times: at baseline, following 6 and 12 sessions. A satisfactory questionnaire will be filled out by each patient twice, following 6 and 12 sessions. The study will test for no differences in the overall progress of the patients during the 12-session rehabilitation period. The study will further test for differences in all outcome measures between the manipulated and non-manipulated treatment sessions.

Registry
clinicaltrials.gov
Start Date
August 2017
End Date
October 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Isabella Shvartz
Responsible Party
Sponsor Investigator
Principal Investigator

Isabella Shvartz

MD

Hadassah Medical Organization

Eligibility Criteria

Inclusion Criteria

  • Restricted shoulder motion (up to 90 degrees in abduction and flexion) following proximal humerus fracture, 4 weeks to 6 months following injury, without rotatory cuff tear
  • Normal or corrected eyesight and hearing.

Exclusion Criteria

  • Neurological deficiencies that restrict upper limb.
  • Previous injury to the shoulder

Outcomes

Primary Outcomes

Shoulder range of motion

Time Frame: 12 weeks

Secondary Outcomes

  • Pain level(12 weeks)
  • The Disabilities of the Arm, Shoulder and Hand questionnaire(12 weeks)

Study Sites (1)

Loading locations...

Similar Trials