NCT02232295

Brief Summary

The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor functions and quality of life in patients with stroke that was conducted in two centers in india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary outcome measure was quality of life at 6 weeks. Research Hypothesis: There would be significant effect of GMI on Upper limb motor functions and quality of life in patients with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

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, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 29, 2014

Last Update Submit

September 4, 2014

Conditions

Keywords

Upper extremity, motor imagery, mirror therapy

Outcome Measures

Primary Outcomes (1)

  • Upper limb motor functions

    Primary Outcome measures: FMA Scale and CAHAI scale FMA Scale: It is a stroke specific, performance based impairment index. This scale includes items related to movements of the shoulder, elbow, forearm, wrist, and hand in the upper extremity, as well as the hip, knee, and ankle in the lower extremity. For the present study, only the upper extremity was measured.The total score on the upper extremity part of the FMA ranged from 0 (hemiplegia) to a maximum of 66 points (normal motor performance). The scale was measured at baseline and post intervention. CAHAI Scale: The purpose of this measure is to evaluate the functional ability of the hemiplegic arm and hand to perform tasks. It is designed to encourage the bilateral hand to complete the task.Each task was demonstrated once before performance, then the Score was evaluated of the affected upper extremity using the 7 point activity scale from total assistance (1) to complete

    six weeks

Secondary Outcomes (1)

  • Quality of life

    6 weeks

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

Conventional group consist of Upper extremity task oriented functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities.

Device: Mirror Box

Graded Motor imagery group and Conventional group

EXPERIMENTAL

Graded Motor imagery is a three stage process, was performed five days a week for six weeks of one hour duration. It comprises of: * Left Right discrimination training (Implicit Motor Imagery) - 2 weeks * Explicit Motor Imagery (Imagined movements) - 2 weeks * Mirror Therapy - 2 weeks

Device: Recognise [TM]

Interventions

Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.

Also known as: Online Recognise software by the NOI group, Australia
Graded Motor imagery group and Conventional group

A resource used for many pain and disability states of the hands and feet.

Conventional group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age (between 45 to 65 years)
  • Individuals who experienced one episode of stroke only.
  • Both males and females were included in the study
  • Both ischemic \& haemorrhagic stroke individuals were included in the study
  • Duration of stroke between 1 to 6 months
  • Mini mental status examination (MMSE) (score \> 23)
  • Patients with Brunnstrom stage 1 \& 2

You may not qualify if:

  • Individuals having any musculoskeletal disorders
  • Individuals having any neurological disorder other than stroke
  • Individuals with any visual impairment
  • Individuals having any systemic disease
  • Non cooperative patients
  • Patients suffering from psychological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana

Ambāla, Haryana, 133207, India

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Manisha Uttam, Masters in Physiotherapy

    Maharishi Markandeshwar University, Mullana-Ambala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 5, 2014

Study Start

April 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations