Cross Education in Patients With Sensorimotor Impairment
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of training of the non-involved upper limb on the motor ability of the hemiparetic upper limb in patients with unilateral sensorimotor motor impairments. The secondary aims are to investigate the relation between lesion characteristics and responsiveness to the treatment, and to study which brain structures are activated during a task trained in the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedSeptember 1, 2017
August 1, 2017
2.8 years
June 6, 2016
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fugl-Meyer Assessment
Score of 66 point indicate normal motor functioning of upper limb
3 weeks
Secondary Outcomes (2)
Change in Box and blocks test
3 weeks
Number of flexion movements of the fingers during half a minute
3 weeks
Study Arms (2)
Device with feedback & exercises
EXPERIMENTALTraining using Rehabit-Tec System - patient's hand will be positioned in this specialized motion control apparatus which allows movement of the non involved hand while receiving visual feedback of a virtual hand in the paretic side and a passive movement of the paretic hand + followed by 30 minutes of exercises (conventional sensorimotor active and passive exercises of the upper limb). 5 days per week for 3 weeks, 1 hour per day.
Device without feedback & exercises
ACTIVE COMPARATORTraining using Rehabit-Tec System - patient's hand will be positioned in a specialized motion control apparatus which allows movement of the non involved hand but without receiving visual feedback of a virtual hand in the paretic side and a passive movement of the paretic hand + followed by 30 minutes of exercises (conventional sensorimotor active and passive exercises of the upper limb). 5 days per week for 3 weeks, 1 hour per day.
Interventions
Eligibility Criteria
You may qualify if:
- Having unilateral motor and/or sensory impairment of the upper limb due to neurological disorder
- Able to provide informed consent
You may not qualify if:
- For patients who will be asked to participate in the fMRI/DTI examination only: having pacemakers and metal body
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nachum Soroker, MDlead
- Tel Aviv Universitycollaborator
Study Sites (1)
Loewenstain hospital
Raanana, Israel
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Nachum Soroker
Loewenstein rehabilitation hospital, Raanana, ISRAEL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- head, Department of neurologic rehabilitation, Loewenstein rehabilitation hospital, Raanana,Israel
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 10, 2016
Study Start
July 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
September 1, 2017
Record last verified: 2017-08