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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: specific training of paretic upper limb

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With restraint; The group with restraint underwent specific training of paretic upper limb and use of restraint.	Other: specific training of paretic upper limb; 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
Active Comparator: no restraint; The group control "without restraint" submitted only to the specific training of paretic upper limb	Other: specific training of paretic upper limb; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): June 20, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: balance; cognitive; hemiparetic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NCI-2012-MDTR, Brazil