NCT03196674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

June 21, 2017

Last Update Submit

August 8, 2017

Conditions

Fracture Humerus

Outcome Measures

Primary Outcomes (1)

  • Shoulder range of motion

    12 weeks

Secondary Outcomes (2)

  • Pain level

    12 weeks

  • The Disabilities of the Arm, Shoulder and Hand questionnaire

    12 weeks

Study Arms (2)

manipulated feedback

ACTIVE COMPARATOR
Other: Biofeedback via motion capture

non-manipulated feedback

ACTIVE COMPARATOR
Other: Biofeedback via motion capture

Interventions

Biofeedback via motion captureOTHER

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.

manipulated feedbacknon-manipulated feedback

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91240, Israel

Location

Related 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.

    PMID: 19713617BACKGROUND

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Isabella Schwartz, MD

CONTACT

(972) -(0)2-5844474isabellas@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 23, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

IL(1)