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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: specific training of paretic upper limb

• Registration Number: NCT01623973
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-19
• Last Update Submitted: 2012-06-19
• Study First Posted: 2012-06-20
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With restraint	specific training of paretic upper limb	The group with restraint underwent specific training of paretic upper limb and use of restraint.
no restraint	specific training of paretic upper limb	The group control "without restraint" submitted only to the specific training of paretic upper limb

Primary Outcome Measures

Name	Time	Method
To investigate the impact that the restriction of non-paretic upper limb recovery would have on sensorimotor with Fugl-Meyer Scale	1 year	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).

Secondary Outcome Measures

Name	Time	Method
Functional Independence Measure (FIM)	1 year	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.