The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma
Primary Purpose
Fracture Humerus
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Biofeedback via motion capture
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Humerus
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
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
manipulated feedback
non-manipulated feedback
Arm Description
Outcomes
Primary Outcome Measures
Shoulder range of motion
Secondary Outcome Measures
Pain level
The Disabilities of the Arm, Shoulder and Hand questionnaire
Full Information
NCT ID
NCT03196674
First Posted
June 21, 2017
Last Updated
August 8, 2017
Sponsor
Isabella Shvartz
Collaborators
Sigal Portnoy, Uri Safran, Shaul Beit
1. Study Identification
Unique Protocol Identification Number
NCT03196674
Brief Title
The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma
Official Title
The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Isabella Shvartz
Collaborators
Sigal Portnoy, Uri Safran, Shaul Beit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Humerus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
manipulated feedback
Arm Type
Active Comparator
Arm Title
non-manipulated feedback
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Biofeedback via motion capture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shoulder range of motion
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain level
Time Frame
12 weeks
Title
The Disabilities of the Arm, Shoulder and Hand questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabella Schwartz, MD
Phone
(972) -(0)2-5844474
Email
isabellas@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
19713617
Citation
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.
Results Reference
background
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The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma
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