StrokeNCT02232295
A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.
A study testing Recognise [TM] and Mirror Box in people with Stroke, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Recognise [TM] and Mirror Box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana
Ambāla, Haryana, 133207
About this study
Official title: 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.
Read the 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
- Conditions
- Stroke
- Being tested
- Recognise [TM], Mirror Box
- Keywords
- Upper extremity, motor imagery, mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recognise [TM]Device
Also called Online Recognise software by the NOI group, Australia
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 BoxDevice
A resource used for many pain and disability states of the hands and feet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Recognise [TM] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manisha Uttam, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Manisha Uttam, Masters in Physiotherapy, Principal investigator, Maharishi Markandeshwar University, Mullana-Ambala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232295
- Sponsor's protocol ID
- M44-124
- Status last verified
- Sep 2014
- First submitted
- 29 Aug 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke
- ClinicalTrials.gov ID
- NCT02232295
- Acronym / sponsor ID
- M44-124
- Conditions
- Stroke
- Keywords
- Upper extremity, motor imagery, mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Device: Mirror BoxConventional 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 group and Conventional group | Experimental | Device: Recognise [TM]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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recognise [TM]Also: Online Recognise software by the NOI group, AustraliaRecognise 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. | Device | Graded Motor imagery group and Conventional group |
| Mirror BoxA resource used for many pain and disability states of the hands and feet. | Device | Conventional group |
Primary outcome
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
1 secondary outcome
Quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Uttam, Masters in Physiotherapy principal investigator
Maharishi Markandeshwar University, Mullana-Ambala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recognise [TM] and Mirror Box in people with Stroke, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb motor functions (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.