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

NCT01623973 | Completed DMC

• 1 other identifier: NCI-2012-MDTR, Brazil
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stroke

Keywords

hemiparetic; cognitive; balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Independence Measure (FIM)

  1 year

Study Arms (2)

With restraint

EXPERIMENTAL

The group with restraint underwent specific training of paretic upper limb and use of restraint.

Other: specific training of paretic upper limb

no restraint

ACTIVE COMPARATOR

The group control "without restraint" submitted only to the specific training of paretic upper limb

Other: specific training of paretic upper limb

Interventions

specific training of paretic upper limb OTHER

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

With restraint; no restraint

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to actively extend at least 10° at the metacarpophalangeal the wrist;
• more than 6 months post onset of stroke;

You may not qualify if:

• Mini-Mental State Examination;
• no excessive spasticity in any joints of the affected.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Impact of restriction of the non-paretic upper limb rehabilitation of patients after stroke: a randomized blinded clinical trial

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 20, 2012
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-06