CClinicalTrials.gg
Status unknownNCT03196674Updated Aug 9, 2017

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

An interventional study of Biofeedback via motion capture in Fracture Humerus, sponsored by Isabella Shvartz. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-09.

Sponsored by Isabella Shvartz · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fracture Humerus

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03

In context

Humeral Fractures

175 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.

This study's planned enrollment of 30 is below the median of 55 across 99 interventional studies indexed under Humeral Fractures.

Browse Humeral Fractures studies →

Lead sponsor

This is the only study on the registry with Isabella Shvartz as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Neurological deficiencies that restrict upper limb.
  • Previous injury to the shoulder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    manipulated feedback

    Other: Biofeedback via motion capture

  • Active comparator
    non-manipulated feedback

    Other: Biofeedback via motion capture

Interventions

  • OtherBiofeedback 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.

06

What researchers measure

Primary outcomes

  1. Shoulder range of motion

    Time frame: 12 weeks

Secondary outcomes

  1. Pain level

    Time frame: 12 weeks

  2. The Disabilities of the Arm, Shoulder and Hand questionnaire

    Time frame: 12 weeks

07

Study locations

1 site
  • Hadassah Medical Center
    Jerusalem, 91240, Israel
08

References and documents

Publications

  • 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. PubMed 19713617 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03196674
Lead sponsor
Isabella Shvartz
Collaborators
Sigal Portnoy, Uri Safran, Shaul Beit
Responsible party
Isabella Shvartz (MD, Hadassah Medical Organization) — Sponsor-investigator
First posted
Jun 23, 2017
Start date
Aug 2017 (estimated)
Primary completion
Aug 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Aug 9, 2017

Study contacts

Isabella Schwartz, MD
Contact
isabellas@hadassah.org.il
(972) -(0)2-5844474
Hadas Lemberg, PhD
Contact
lhadas@hadassah.org.il
00 972 2 6777572

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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