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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623973
• Other study ID #: NCI-2012-MDTR, Brazil
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: June 19, 2012
• Start date: March 2011

Study information

• Verified date: June 2012
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes