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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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ClinicalTrials.gov Identifier: NCT02232295
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Manisha Uttam, Maharishi Markendeswar University

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Recognise [TM] Device: Mirror Box Not Applicable

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  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

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 Name: Online Recognise software by the NOI group, Australia




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232295


Locations
India
Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Maharishi Markendeswar University
Investigators
Principal Investigator: Manisha Uttam, Masters in Physiotherapy Maharishi Markandeshwar University, Mullana-Ambala

Responsible Party: Manisha Uttam, Physiotherapist, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT02232295     History of Changes
Other Study ID Numbers: M44-124
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Manisha Uttam, Maharishi Markendeswar University:
Upper extremity, motor imagery, mirror therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases