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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232295
• Other study ID #: M44-124
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: September 4, 2014
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Institutional Ethics review board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
India	Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	6 weeks	Yes