Impact of Restriction of the Non Paretic Upper Limb Rehabilitation of Patients a With Stroke:Randomized Clinical Trial

Study Overview
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Brief Summary
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To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. In this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL

Official Title
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Impact of the Restriction of the Non Paretic Upper Limb in Rehabilitation of Patients Post-stroke:Randomized Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: specific training of paretic upper limb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to actively extend at least 10° at the metacarpophalangeal the wrist; more than 6 months post onset of stroke; Exclusion Criteria: Mini-Mental State Examination; no excessive spasticity in any joints of the affected.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With restraint<br>The group with restraint underwent specific training of paretic upper limb and use of restraint. | Other: specific training of paretic upper limb<br>* nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment<br>|
| Active Comparator: no restraint<br>The group control without restraint submitted only to the specific training of paretic upper limb | Other: specific training of paretic upper limb<br>* nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale | Upper extremity motor impairment was evaluated using the Fugl-Meyer Assessment Scale (FM).This scale has a total score of 66 points for upper limbs, reflecting a mild motor impairment (≥ 50), moderate to severe (50-20) and severe (< 20). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) | The FIM consists of 18 items divided into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 based on the required level of assistance to perform the basic ADL (maximum score, 126). Higher scores demonstrate greater independent participation in daily activities. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiparetic, cognitive, balance