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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Recognise [TM]
Mirror Box
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Upper extremity, motor imagery, mirror therapy

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional group

Graded Motor imagery group and Conventional group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life
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.

Full Information

First Posted
August 29, 2014
Last Updated
September 4, 2014
Sponsor
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT02232295
Brief Title
A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.
Official Title
To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper extremity, motor imagery, mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Graded Motor imagery group and Conventional group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Recognise [TM]
Other Intervention Name(s)
Online Recognise software by the NOI group, Australia
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mirror Box
Intervention Description
A resource used for many pain and disability states of the hands and feet.
Primary Outcome Measure Information:
Title
Upper limb motor functions
Description
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
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Uttam, Masters in Physiotherapy
Organizational Affiliation
Maharishi Markandeshwar University, Mullana-Ambala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

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

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