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

NCT ID: NCT01623973

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With restraint

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

Group Type: EXPERIMENTAL

specific training of paretic upper limb

Intervention Type: 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

no restraint

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

Group Type: ACTIVE_COMPARATOR

specific training of paretic upper limb

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Luciana B. dos Santos, PT

Impact of restriction of the non-paretic upper limb rehabilitation of patients after stroke: a randomized blinded clinical trial

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NCI-2012-MDTR, Brazil

Identifier Type: -

Identifier Source: org_study_id