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

Not Applicable

• Conditions: Fracture Humerus
• Interventions: Other: Biofeedback via motion capture

• Registration Number: NCT03196674
• Lead Sponsor: Isabella Shvartz

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.

Study Timeline

• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Status Verified: 2017-08
• Study Start: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09
• Primary Completion: 2018-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manipulated feedback	Biofeedback via motion capture	-
non-manipulated feedback	Biofeedback via motion capture	-

Primary Outcome Measures

Name	Time	Method
Shoulder range of motion	12 weeks

Secondary Outcome Measures

Name	Time	Method
Pain level	12 weeks
The Disabilities of the Arm, Shoulder and Hand questionnaire	12 weeks

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel