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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fracture Humerus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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manipulated feedback

Group Type ACTIVE_COMPARATOR

Biofeedback via motion capture

Intervention Type OTHER

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.

non-manipulated feedback

Group Type ACTIVE_COMPARATOR

Biofeedback via motion capture

Intervention Type OTHER

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.

Interventions

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Biofeedback via motion capture

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.

Intervention Type OTHER

Eligibility Criteria

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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.