Effects of Task-Based Mirror Therapy for Post-stroke Shoulder-Hand Syndrome

Official title

Effects of Task-based Mirror Therapy on Edema, Pain and Upper Limb Motor Function for Post-stroke Shoulder-hand Syndrome

Overview

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.

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.

Interventions

• Other 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
• Other 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

Primary outcome measures

• Numeric pain rating scale (NPRS) [Time frame: Baseline]
• Numeric Pain Rating Scale (NPRS) [Time frame: 4 weeks]

Secondary outcome measures (4)

• Figure of 8 measurement method [Time frame: Baseline]
• Figure of 8 measurement method [Time frame: 4 weeks]
• Functional independence measure [FIM] [Time frame: Baseline]
• Functional Independence Measure (FIM) [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 2 centers

• Alara healthcare clinic — Lahore
• Ittefaq Hospital and Trust Lahore — Lahore

Publications

• 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. PMID 34158602
• 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. PMID 38517771
• 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. PMID 36703623
• 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. PMID 33675672
• 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. PMID 38605413

Identifiers

NCT: NCT07428811 · REC/0285 Maha Sahar

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗