A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.

September 4, 2014 updated by: Manisha Uttam, Maharishi Markendeswar University (Deemed to be University)

To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Graded Motor Imagery (GMI) is essentially a brain based treatment, targeting the activation of different brain regions in a graded manner. GMI is a three stage treatment programme comprising of Left Right discrimination training, Explicit Motor imagery and Mirror therapy.

In this Study, GMI approach is applied on the patients with Stroke to enhance their Upper limb motor functions and Quality of life.

Conventional treatment:

Patients of group A and group B had received conventional treatment for 6 weeks. Conventional treatment consists of Task oriented upper extremity functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities. It was performed five days a week for six weeks of one hour duration.

Graded Motor Imagery:

Patients of group A had received GMI programme with conventional treatment for 6 weeks. It 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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambala, Haryana, India, 133207
        • Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional group
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
A resource used for many pain and disability states of the hands and feet.
Experimental: Graded Motor imagery group and Conventional group

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]
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.
Other Names:
  • Online Recognise software by the NOI group, Australia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb motor functions
Time Frame: six weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 6 weeks

Secondary outcome measure:

SS-QOL (Stroke Specific- Quality of life) Scale It is a self report scale containing 49 items in 12 domains. It is intended to provide an assessment of health related quality of life specific to patients with stroke. Scale domains and items were derived from a series of interviews with patients.The scale was measured at baseline and post intervention.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: Manisha Uttam, Masters in Physiotherapy, Maharishi Markandeshwar University, Mullana-Ambala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M44-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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