StrokeNCT06108440
Comparative Effects of Action Observation and Motor Imagery on Upper Limb in Chronic Stroke Patients
A study testing action observation training and motor imagery training in people with Stroke and Upper Extremity Paresis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Motor Activity
- What is being tested?
- action observation training and motor imagery training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Aug 2023to 1 Feb 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with chronic stroke by a neurologist
- 03 months post stroke
- Score 1+ on modified ashworth scale
- Having a score of 24 or higher in the Mini-Mental State Examination
Who cannot join
- Patient with neurological condition other than stroke e.g. Parkinson's or multiple sclerosis
- Presence of an attached artificial pacemaker
- Presence of a metal implant in the brain
- Presence of visual impairment
- Presence of unilateral neglect in Line bisection test (25)
- Use of antipsychotic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Action Observation and Motor Imagery Training on Upper Limb Function in Chronic Stroke Patients
To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.
Read the detailed description
The study is Randomized controlled trial. The study will be conducted on 44 stroke patients. The study will be conducted in Civil Hospital Shujaabad and Riphah rehabilitation centre Lahore. Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. For the pre- and post-evaluation of all participants, Fugl-Meyer Assessment Upper Extremity (FMA UE) and Wolf Motor Function Test (WMFT) will be used. Data will be analyzed by using SPSS (Statistical package for Social Sciences) 25 version.
- Conditions
- Stroke, Upper Extremity Paresis, Motor Activity
- Being tested
- action observation training, motor imagery training
- Keywords
- Stroke, Upper Extremity Paresis, Motor Activity
- Medical subject headings
- Stroke, Paresis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
action observation trainingOther
Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks.
motor imagery trainingOther
Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| action observation training group | Experimental | Patients in Group A will receive action observation training with conventional treatment. Receives: Other: action observation training |
| motor imagery training group | Active comparator | Patients in Group B will receive motor imagery with conventional treatment. Receives: Other: motor imagery training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA UE):
Fugl-Meyer Assessment Upper Extremity (FMA UE):
FMA UE is a detailed evaluation tool that quantitatively measures motor function, balance, sensation, joint range of motion, and pain in stroke hemiplegic patients
Measured: 6 months
Wolf Motor Function Test (WMFT):
Wolf Motor Function Test (WMFT):
The Wolf motor function test is a tool to evaluate upper extremity motor function in hemiplegic patients. It has 17 tasks with a score range from 0-5. The inter-rater reliability of the function score is 0.88 and the inter-rated reliability of performance time is 0.97
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start3 Aug 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest Hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108440
- Sponsor's protocol ID
- REC/RCR & AHS/23/0232
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demartino AM, Rodrigues LC, Gomes RP, Michaelsen SM. Hand function and type of grasp used by chronic stroke individuals in actual environment. Top Stroke Rehabil. 2019 May;26(4):247-254. doi: 10.1080/10749357.2019.1591037. Epub 2019 Mar 23.
PubMed 30907287Veldema J, Nowak DA, Gharabaghi A. Resting motor threshold in the course of hand motor recovery after stroke: a systematic review. J Neuroeng Rehabil. 2021 Nov 3;18(1):158. doi: 10.1186/s12984-021-00947-8.
PubMed 34732203Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
PubMed 33076218Serlin Y, Shelef I, Knyazer B, Friedman A. Anatomy and physiology of the blood-brain barrier. Semin Cell Dev Biol. 2015 Feb;38:2-6. doi: 10.1016/j.semcdb.2015.01.002. Epub 2015 Feb 11.
PubMed 25681530
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Action Observation and Motor Imagery Training on Upper Limb Function in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06108440
- Acronym / sponsor ID
- REC/RCR & AHS/23/0232
- Conditions
- Stroke, Upper Extremity Paresis, Motor Activity
- Keywords
- Stroke, Upper Extremity Paresis, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- 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.
To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.
Detailed description
The study is Randomized controlled trial. The study will be conducted on 44 stroke patients. The study will be conducted in Civil Hospital Shujaabad and Riphah rehabilitation centre Lahore. Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. For the pre- and post-evaluation of all participants, Fugl-Meyer Assessment Upper Extremity (FMA UE) and Wolf Motor Function Test (WMFT) will be used. Data will be analyzed by using SPSS (Statistical package for Social Sciences) 25 version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.
| Arm | Type | Receives |
|---|---|---|
| action observation training group | Experimental | Other: action observation trainingPatients in Group A will receive action observation training with conventional treatment. |
| motor imagery training group | Active comparator | Other: motor imagery trainingPatients in Group B will receive motor imagery with conventional treatment. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with chronic stroke by a neurologist
- 03 months post stroke
- Score 1+ on modified ashworth scale
- Having a score of 24 or higher in the Mini-Mental State Examination
Key exclusion criteria (6 listed)
- Patient with neurological condition other than stroke e.g. Parkinson's or multiple sclerosis
- Presence of an attached artificial pacemaker
- Presence of a metal implant in the brain
- Presence of visual impairment
- Presence of unilateral neglect in Line bisection test (25)
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 |
|---|---|---|
| action observation trainingPatients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. | Other | action observation training group |
| motor imagery trainingPatients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. | Other | motor imagery training group |
Primary outcome
Fugl-Meyer Assessment Upper Extremity (FMA UE):
Time frame: 6 months
Fugl-Meyer Assessment Upper Extremity (FMA UE): FMA UE is a detailed evaluation tool that quantitatively measures motor function, balance, sensation, joint range of motion, and pain in stroke hemiplegic patients
Wolf Motor Function Test (WMFT):
Time frame: 6 months
Wolf Motor Function Test (WMFT): The Wolf motor function test is a tool to evaluate upper extremity motor function in hemiplegic patients. It has 17 tasks with a score range from 0-5. The inter-rater reliability of the function score is 0.88 and the inter-rated reliability of performance time is 0.97
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 15 Mar 2024.
- Background: PubMed 30907287Demartino AM, Rodrigues LC, Gomes RP, Michaelsen SM. Hand function and type of grasp used by chronic stroke individuals in actual environment. Top Stroke Rehabil. 2019 May;26(4):247-254. doi: 10.1080/10749357.2019.1591037. Epub 2019 Mar 23.
- Background: PubMed 34732203Veldema J, Nowak DA, Gharabaghi A. Resting motor threshold in the course of hand motor recovery after stroke: a systematic review. J Neuroeng Rehabil. 2021 Nov 3;18(1):158. doi: 10.1186/s12984-021-00947-8.
- Background: PubMed 33076218Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
- Background: PubMed 25681530Serlin Y, Shelef I, Knyazer B, Friedman A. Anatomy and physiology of the blood-brain barrier. Semin Cell Dev Biol. 2015 Feb;38:2-6. doi: 10.1016/j.semcdb.2015.01.002. Epub 2015 Feb 11.
- Individual participant dataSharing planned: No
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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.
Zeest Hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing action observation training and motor imagery training in people with Stroke and Upper Extremity Paresis, run by Riphah International University at 1 site in Pakistan.
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 4 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 15 Mar 2024. 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 Pakistan. 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?
Fugl-Meyer Assessment Upper Extremity (FMA UE): (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108440, which also lists 4 linked publications.
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 15 Mar 2024.