- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428811
Effects of Task-Based Mirror Therapy for Post-stroke Shoulder-Hand Syndrome
Effects of Task-based Mirror Therapy on Edema, Pain and Upper Limb Motor Function for Post-stroke Shoulder-hand Syndrome
The study aims to determine the effects of task-based mirror therapy on edema, pain and upper limb motor function with shoulder-hand syndrome in post stroke patients.
This randomized clinical trial will take place at Ittefaq Hospital and Trust Lahore and Alara healthcare clinic, Lahore involving 34 participants aged 45-75 years. Using a non-probability convenience sampling method, participants will be randomly assigned by online randomizing tool into two groups: experimental group (17 participants) and control group (17 participants). Both groups will undergo treatment for 30 minutes a day, five days a week, over four weeks. Each task will be performed by repeating each movement 20 times per set for three sets, with a 2-minute break between sets. There will also be 2-minute intervals between each completed task Outcome measures will include pain intensity assessed by the Numeric Pain Rating Scale (NPRS), edema measured by the figure-of-eight method, and upper limb motor function evaluated using the Functional Independence measure (FIM). Assessments will occur at baseline and post-intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a sudden neurological loss caused by cerebral vascular damage. Upper extremity paralysis is the most prevalent symptom in stroke patients. Stroke-related paralysis is typically caused by internal capsule injury. Neuroplasticity, which involves multiple sections of the brain, is necessary to heal from this damage.Upper extremity function makes up 60% of total body function, with hand function accounting for 90% of that. Shoulder-hand syndrome (SHS), a chronic neurological condition that can develop after a stroke, is defined by excruciating discomfort, edema, vasomotor instability, and impaired motor performance. SHS is often referred to as reflex sympathetic dystrophy of the upper limb or poststroke complicated regional pain syndrome (CRPS). The development of upper limb discomfort and edema observed in SHS was attributed to hemiparetic arms. After a stroke autonomic and motor dysfunction, as well as upper limb pain, can be symptoms of SHS. Pathophysiologic mechanisms may include somatosensory and central autonomic system in brain, peripheral sensitization as hyperexcitability of the afferent fibers and inflammation of peripheral nerves and central mechanism as maladaptive neuroplasticity of motor cortex.
Mirror therapy is an attractive treatment option for clinical practice because it is simple to implement, relatively inexpensive, less intimidating for patients, and often equally or more effective than many alternative treatments. However, not all mirror therapy studies involving stroke victims have yielded such encouraging results. One study observed that the positive effects of mirror therapy decreased over time, and that mirror therapy involving the repetition of simple movements produced improvements during the start of treatment but were followed by a gradual decrease in function as the patients became bored with the movements and began resisting therapy. Based on this observation, mirror therapy programs that incorporate a variety of functional tasks were proposed to be more effective than those involving only simple movements designed to mimic tasks. It was also suggested the use more functional and task-oriented programs that involved picking up a coin because simple movements restrict the functional recovery of more complicated movements performed using the upper extremity. It was observed that treatment was more effective when an actual coin was used rather than when the same motion was performed without a coin.
Traditional rehabilitation methods often inadequately address the specific symptoms of SHS, creating a compelling case for innovative approaches like TBMT. This method uses visual feedback to improve motor function while engaging patients in purposeful, task-oriented exercises. Mirror treatment improves brain plasticity and motor recovery. This study will help us understand the effects of this treatment method and will pay ways for upgraded treatment strategies to improve symptoms and may have better outcomes and prognosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maha Sahar, MSPT-NM
- Phone Number: 03003424449
- Email: mahasahar5@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Recruiting
- Alara healthcare clinic
-
Contact:
- Maha Sahar, MSPT-NM
- Phone Number: 03003424449
- Email: mahasahar5@gmail.com
-
Lahore, Punjab Province, Pakistan
- Recruiting
- Ittefaq Hospital and Trust Lahore
-
Contact:
- Maha Sahar, MSPT-NM
- Phone Number: 03003424449
- Email: mahasahar5@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Age 45 to 75 years.
- Both male and female patients are included in the study.
- Subacute stroke patients having stroke less than 6 months are included in this study.
- Stable participants having a stroke severity score > 6 on National Institute of Health Stroke Scale (NIHSS).
- Modified Ashworth scale score ≤ 2 of the affected upper extremity.
- Montreal Cognitive Assessment (MoCA) score ≥ 24.
- Patients who can sit with or without support.
- No contractures of the affected shoulder, elbow, wrist and fingers.
- Participants who have no history of peripheral nerve injury or musculoskeletal disease
Exclusion Criteria:
• Participants who have medical problems or co-morbidities that interdict their participation in the study.
- Patients with severe apraxia, somatosensory problems.
- Unilateral neglect
- Severe contractures of the affected shoulder, elbow, wrist and finger.
- Participants who show the symptoms of global or receptive aphasia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group A
Task based mirror therapy
|
Group A will undergo treatment for 30 minutes a day, five days a week, over four weeks.
Each task will be performed by repeating each movement 20 times per set for three sets, with a 2-minute break between sets.
There will also be 2-minute intervals between each completed task
|
|
Active Comparator: group B
Conventional exercises
|
Group B will undergo treatment for 30 minutes a day, five days a week, over four weeks.
Each task will be performed by repeating each movement 20 times per set for three sets, with a 2-minute break between sets.
There will also be 2-minute intervals between each completed task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale (NPRS)
Time Frame: Baseline
|
The Numeric Pain Rating Scale (NPRS) is an effective tool for assessing pain intensity in stroke patients, utilizing a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst pain imaginable."
This scale is particularly valuable in stroke populations due to its simplicity and quick administration, allowing for effective communication of pain levels even in individuals with cognitive or physical impairments.
|
Baseline
|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4 weeks
|
The Numeric Pain Rating Scale (NPRS) is an effective tool for assessing pain intensity in stroke patients, utilizing a scale from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst pain imaginable."
This scale is particularly valuable in stroke populations due to its simplicity and quick administration, allowing for effective communication of pain levels even in individuals with cognitive or physical impairments.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Figure of 8 measurement method
Time Frame: Baseline
|
Figure 8 measurement method is a practical technique used to assess edema in the hand, particularly following a stroke.
This method involves wrapping a flexible measuring tape around the hand and wrist in a figure-eight pattern, allowing for consistent measurements at specific anatomical points.
It begins by placing the tape at the ulnar aspect of the wrist, passing it across the palm and around the fingers, and then returning to the starting point.
Abnormal values indicating edema may be defined as an increase of more than 1-2 cm compared to the unaffected hand, signifying potential swelling due to conditions such as stroke, trauma, or inflammation
|
Baseline
|
|
Figure of 8 measurement method
Time Frame: 4 weeks
|
Figure 8 measurement method is a practical technique used to assess edema in the hand, particularly following a stroke.
This method involves wrapping a flexible measuring tape around the hand and wrist in a figure-eight pattern, allowing for consistent measurements at specific anatomical points.
It begins by placing the tape at the ulnar aspect of the wrist, passing it across the palm and around the fingers, and then returning to the starting point.
Abnormal values indicating edema may be defined as an increase of more than 1-2 cm compared to the unaffected hand, signifying potential swelling due to conditions such as stroke, trauma, or inflammation
|
4 weeks
|
|
Functional independence measure [FIM]
Time Frame: Baseline
|
The Functional Independence Measure (FIM) assesses a patient's level of independence in daily activities following a stroke.
It includes various domains such as self-care, mobility, and social cognition.
An admission FIM score > 70 has been associated with achieving non-dependence by discharge whereas those with an admission score < 50 remained dependent
|
Baseline
|
|
Functional Independence Measure (FIM)
Time Frame: 4 weeks
|
The Functional Independence Measure (FIM) assesses a patient's level of independence in daily activities following a stroke.
It includes various domains such as self-care, mobility, and social cognition.
An admission FIM score > 70 has been associated with achieving non-dependence by discharge whereas those with an admission score < 50 remained dependent
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Binash Afzal, PHD, Riphah International University
Publications and helpful links
General Publications
- Feng S, Tang M, Huang G, Wang J, He S, Liu D, Gu L. EMG biofeedback combined with rehabilitation training may be the best physical therapy for improving upper limb motor function and relieving pain in patients with the post-stroke shoulder-hand syndrome: A Bayesian network meta-analysis. Front Neurol. 2023 Jan 10;13:1056156. doi: 10.3389/fneur.2022.1056156. eCollection 2022.
- Lee JI, Kwon SW, Lee A, Tae WS, Pyun SB. Neuroanatomical correlates of poststroke complex regional pain syndrome: a voxel-based lesion symptom-mapping study. Sci Rep. 2021 Jun 22;11(1):13093. doi: 10.1038/s41598-021-92564-7.
- Li L, Li J, He M. Treatment outcomes in post-stroke shoulder-hand syndrome: The role of combined acupuncture, traditional Chinese herb hot compress and rehabilitation training. J Back Musculoskelet Rehabil. 2024;37(4):1023-1030. doi: 10.3233/BMR-230267.
- Saha S, Sur M, Ray Chaudhuri G, Agarwal S. Effects of mirror therapy on oedema, pain and functional activities in patients with poststroke shoulder-hand syndrome: A randomized controlled trial. Physiother Res Int. 2021 Jul;26(3):e1902. doi: 10.1002/pri.1902. Epub 2021 Mar 6.
- Liu H, Xu Y, Jiang W, Hu F, Zhou Y, Pan L, Zhou F, Yin Y, Tan B. Effects of task-based mirror therapy on upper limb motor function in hemiplegia: study protocol for a randomized controlled clinical trial. Trials. 2024 Apr 11;25(1):254. doi: 10.1186/s13063-024-08081-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Complex Regional Pain Syndromes
- Pain
- Stroke
- Edema
- Reflex Sympathetic Dystrophy
Other Study ID Numbers
- REC/0285 Maha Sahar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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