StrokeMTNCT06698380
The Effect of Mirror Therapy on Upper Extremity Motor Function in Stroke Rehabilitation
A study testing Conventional Physical Therapy and Mirror Therapy in people with Stroke and Chronic Stroke Patients, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects. Research Objectives: 1. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Chronic Stroke Patients, Hemiplegia
- What is being tested?
- Conventional Physical Therapy and Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Nov 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Duration of stroke more than six months
- Subjects of chronic stroke with left or right hemiplegia.
- Genders of male and female with age ranging between forty-five to sixty-five years.
- MMSE scores greater than 23 out of 30.
- Scored one or one plus on MAS on all muscles of the affected upper limb.
- Have normal visual perception.
- Able to follow oral commands.
Who cannot join
- Unable to follow visual and oral commands.
- Unilateral neglect.
- Cognitive impairments (MMSE scores less than 24 out of 30), or language deficits.
- Any other neurological disorders and recent surgeries.
- Previous exposure to MT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud Medical City
Riyadh, Riyadh Region
Weam Alsalem, MPT, 0164041122, weam.alsalem@hotmail.com
About this study
The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects.
Research Objectives:
- To discover the effectiveness of conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
- To find out the effect of mirror therapy along with conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
- To find out the effectiveness of mirror therapy combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity motor function among chronic hemiplegic subjects.
- Conditions
- Stroke, Chronic Stroke Patients, Hemiplegia
- Being tested
- Conventional Physical Therapy, Mirror Therapy
- Keywords
- storke, Hemiplegia, mirror therapy, upper extremity, motor function
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyOther
The subjects of the control group received the CPT based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements
Mirror TherapyOther
A mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes followed by 30 minutes of CPT treatment. Each session lasted 45 minutes, held three times per week over six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The participants of control participants received conventional Physical Therapy (CPT) based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements Receives: Other: Conventional Physical Therapy |
| Experimental | Experimental | The experimental group received combination therapy that is MT combined with CPT treatment. The subjects were asked to be seated on a comfortable chair with feet and back supported and the upper extremity was on a tabletop surface of two-by-two- meter size.
A mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes and 30 minutes / 6 weeks. Receives: Other: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
The most widely applied method in post-stroke rehabilitation to estimate gross motor impairment is the FMA. It pursues the concept of stages of recovery for stroke patients, which developed with Twitchell and Brunnstrom. It gauges the capacity to manage isolated joints, which are impeded by synergy, and the strength of muscle, with an assumed order of difficulty. The components of the assessment are five including: joint range of motion (ROM), balance, sensory function, motion of the joint, and joint discomfort. FMA-UE is split into whole, proximal, and distal components and these subtests investigate the movement of body parts independently, with the authors recommending that every part of UE heal alone. It is used in the clinical field and in research to detect disease progress, prescribe exercise recovery, and prepare and evaluate medicine. FMA has as well demonstrated excellent inter- and intra-rater reliability, also the feasibility of construction.
Measured: week 0 and week 6
Wolf Motor Function Test (WMFT)
This examination tool was designed to estimate and evaluate the exercise capacity of individuals who suffer from mild to acute upper extremity motion impairments in laboratory and clinical settings. It is an improvement of a previous examination tool utilized in high-functioning patients, but difficult to perform in patients with minimal capacity of movement in the hands and fingers. WMFT has proven its significance in describing motion status in terms of severity and upper extremity motion impairments in a cohort of chronic individuals who suffer from stroke and traumatic brain injury in high-functioning individuals. The inter-test and inter-rater reliability, internal consistency of tests, and stability for schedule measures of performance and functional ability were high, varying from 0.88 to 0.98, with most estimates' relative from 0.95
Measured: week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start18 Nov 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Collaborators
- King Saud Medical City
- Responsible party
- Principal investigator, Karthick Balasubramanian, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698380
- Sponsor's protocol ID
- MUREC-Apr.13/COM-2022/32-5
- Acronym
- MT
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mirror Therapy on Upper Extremity Motor Function in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06698380
- Acronym / sponsor ID
- MT / MUREC-Apr.13/COM-2022/32-5
- Conditions
- Stroke, Chronic Stroke Patients, Hemiplegia
- Keywords
- storke, Hemiplegia, mirror therapy, upper extremity, motor function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of JazanOther government
- Collaborators
- King Saud Medical City
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
The study aimed to determine the effect of mirror therapy versus conventional physical therapy treatment in improving upper extremity impairments and motor function among chronic hemiplegic subjects.
Research Objectives:
- To discover the effectiveness of conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
- To find out the effect of mirror therapy along with conventional physical therapy treatment on improving upper limb motor function among chronic hemiplegic subjects.
- To find out the effectiveness of mirror therapy combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity motor function among chronic hemiplegic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Conventional Physical TherapyThe participants of control participants received conventional Physical Therapy (CPT) based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements |
| Experimental | Experimental | Other: Mirror TherapyThe experimental group received combination therapy that is MT combined with CPT treatment. The subjects were asked to be seated on a comfortable chair with feet and back supported and the upper extremity was on a tabletop surface of two-by-two- meter size. A mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes and 30 minutes / 6 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)
- Duration of stroke more than six months
- Subjects of chronic stroke with left or right hemiplegia.
- Genders of male and female with age ranging between forty-five to sixty-five years.
- MMSE scores greater than 23 out of 30.
- Scored one or one plus on MAS on all muscles of the affected upper limb.
Key exclusion criteria (5 listed)
- Unable to follow visual and oral commands.
- Unilateral neglect.
- Cognitive impairments (MMSE scores less than 24 out of 30), or language deficits.
- Any other neurological disorders and recent surgeries.
- Previous exposure to MT.
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 |
|---|---|---|
| Conventional Physical TherapyThe subjects of the control group received the CPT based on their routine physical therapy neurological evaluation. The CPT was individualized based on the needs of the subjects. It included: normalization of muscle tone, strengthening of weak muscles, lengthening of tight muscles, training for transfers like supine to sit, sit to stand, balance training, and gait training. The upper extremity training for ADLs also were incorporated using mobilization, reaching, grasping and dexterity movements | Other | Control |
| Mirror TherapyA mirror was positioned in front of the subjects to shield the involved upper extremity, reflecting the image of the uninvolved side. The involved upper extremity was placed in a relaxed posture beside the mirror, mirroring the same posture on the uninvolved side to enhance illusional movements. The MT for the experimental group included reaching, grasping, and dexterity movements of the unaffected upper limb, followed by imitation on the involved side. Subjects performed five activities: finger flexion and extension, finger opposition, counting with fingers, wrist flexion and extension, and forearm supination and pronation. Each activity was done 10 times, with mirror therapy lasting 15 minutes followed by 30 minutes of CPT treatment. Each session lasted 45 minutes, held three times per week over six weeks. | Other | Experimental |
Primary outcome
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time frame: week 0 and week 6
The most widely applied method in post-stroke rehabilitation to estimate gross motor impairment is the FMA. It pursues the concept of stages of recovery for stroke patients, which developed with Twitchell and Brunnstrom. It gauges the capacity to manage isolated joints, which are impeded by synergy, and the strength of muscle, with an assumed order of difficulty. The components of the assessment are five including: joint range of motion (ROM), balance, sensory function, motion of the joint, and joint discomfort. FMA-UE is split into whole, proximal, and distal components and these subtests investigate the movement of body parts independently, with the authors recommending that every part of UE heal alone. It is used in the clinical field and in research to detect disease progress, prescribe exercise recovery, and prepare and evaluate medicine. FMA has as well demonstrated excellent inter- and intra-rater reliability, also the feasibility of construction.
Wolf Motor Function Test (WMFT)
Time frame: week 0 and week 6
This examination tool was designed to estimate and evaluate the exercise capacity of individuals who suffer from mild to acute upper extremity motion impairments in laboratory and clinical settings. It is an improvement of a previous examination tool utilized in high-functioning patients, but difficult to perform in patients with minimal capacity of movement in the hands and fingers. WMFT has proven its significance in describing motion status in terms of severity and upper extremity motion impairments in a cohort of chronic individuals who suffer from stroke and traumatic brain injury in high-functioning individuals. The inter-test and inter-rater reliability, internal consistency of tests, and stability for schedule measures of performance and functional ability were high, varying from 0.88 to 0.98, with most estimates' relative from 0.95
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy and Mirror Therapy in people with Stroke and Chronic Stroke Patients, run by University of Jazan at 1 site in Saudi Arabia.
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 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Mansour Al Shehri, PhD (0503946253, moalshehri@jazanu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (FMA-UE) (time frame: week 0 and week 6). 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?
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 21 Nov 2024.