NCT03762980

Brief Summary

The objective of this study was to evaluate the effects of bilateral training for upper extremity in stroke patients and to compare these effects between right and left stroke patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24 stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B (Left hemiplegia) (n=12). Chronic stroke patients (\>3 months), aged 30-70 years with left or right sided diagnosed stroke patients were included while patients on medication that could affect the cognitive functions or with any other cognitive impairments who are not able to follow commands were excluded. Both groups received the same intervention of with bilateral arm training involving 5 functional tasks to improve the functional activities of daily living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

December 3, 2018

Last Update Submit

April 1, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Wolf Motor Function Test

    The Wolf Motor Function Test (WMFT) was used to assess upper extremity (UE) motor ability through timed and functional tasks

    6 weeks

  • Fugl Meyer Assessment-upper Extremity

    Used to measure upper limb sensorimotor function in stroke patients

    6 weeks

Study Arms (2)

Right hemiplegic patients

EXPERIMENTAL
Other: Bilateral training (BAT)

Left hemiplegic patients

EXPERIMENTAL
Other: Bilateral training (BAT)

Interventions

Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.

Left hemiplegic patientsRight hemiplegic patients

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • left or right-sided chronic stroke patients

You may not qualify if:

  • Patients with cognitive impairment or unable to follow commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bilateral training in stroke patients

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 4, 2018

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

April 3, 2019

Record last verified: 2019-04