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

Fracture Humerus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03196674
• Other study ID #: Shoulder- HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: August 8, 2017
• Start date: August 2017
• Est. completion date: October 2018

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: Isabella Schwartz, MD
• Phone: (972) -(0)2-5844474
• Email: isabellas[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture Humerus
• Humeral Fractures

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (4)

Lead Sponsor	Collaborator
Isabella Shvartz	Shaul Beit, Sigal Portnoy, Uri Safran

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Adamovich SV, Fluet GG, Tunik E, Merians AS. Sensorimotor training in virtual reality: a review. NeuroRehabilitation. 2009;25(1):29-44. doi: 10.3233/NRE-2009-0497. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder range of motion		12 weeks
Secondary	Pain level		12 weeks
Secondary	The Disabilities of the Arm, Shoulder and Hand questionnaire		12 weeks