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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392543
Other study ID # REC/RCR &AHS/22/0205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date January 30, 2023

Study information

Verified date April 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be randomized clinical trial. Non Probability consecutive sampling technique will be used. Data will be collected from patients having stroke by using tools i.e Fugl-Meyer assessment: wrist and hand (FMA- WH) and Brunnstrom Hand Manipulation (BRS-H). Those who will meet inclusion criteria will be recruited. An informed consent will be taken from all patients. The recruited subjects will be assessed according to outcome measures. Patients will be divided into 2 groups. Group A will be treated with Brunnstrom Movement Therapy plus Conventional therapy for 1 hour, 3 sessions per week (4 weeks) and Group B will be treated with Mirror Therapy plus Conventional therapy for 45 min, 3 sessions per week ( 4 weeks) 5 movements, 10 repetitions. Outcome measures will be measured at baseline, 2 weeks and after 4 weeks. Data analysis will be done by Statistical Package for the Social Sciences version 25.


Description:

Stroke commonly known as Cerebro-Vascular Accident (CVA), is stated as a sudden commencement of neurological discrepancy which is attributable to a pivotal vascular basis. In modest words, it is a "brain attack", which occurs when the brain fails to get adequate blood circulation, as a result, brain cells do not get a sufficient amount of oxygen, and cells start dying ultimately. Brunnstrom movement therapy uses reflexes to develop movement behavior through sensory stimulation, in order to inhibit spasticity and movement retraining to enhance recovery. Mirror therapy (MT) in stroke patients involves performing unimpaired limb movements while observing there reflection of the mirror overlapping the impaired limb, creating a visual illusion of increased movement capacity in the impaired limb. In previous researches, various conventional and contemporary approaches such as Brunnstrom, and Mirror therapy have been used to rehabilitate the hand after stroke in clinical settings. Previous literature was focus on digital and other conventional methods. However, despite a revolution in the number of therapeutic protocols, evidence of efficacy remains limited. Both BHM and MT have been studied separately to evaluate their respective effectiveness. However, no study has been found comparing the two protocols exclusively for hand motor recovery.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Both genders - Patient population of adults 40-70 years old - Any type of stroke (ischemic or hemorrhage) - upper extremity, hand impairment - (include stage here) on brunnstorm scale Exclusion Criteria: - inability to follow commands - inability to sit more than 2 h (self-report) - Botox injection/chemo-denervation within the last 6 months - presence of cardiac pacemaker - current participation in other interventions/studies

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Brunnstrom movement therapy.
Group A: Will be treated with Brunnstrom movement therapy for three days in a week for four weeks (1 h) approximately 12 sessions to every subject. Subjects received Brunnstrom hand manipulation (BHM) and conventional occupational therapy for the upper extremity and lower extremities. The detailed BHM is applied on hand. The major goal of the BHM was the acquisition of mass grasp and mass release of objects. Once the goal was achieved, more prehensile activities were focused. Reflexive, passive, synergistic and active movements were used sequentially to enhance the hand recovery.
Mirror Therapy
Group B: Will be treated with Mirror therapy 45 minutes, for three days in a week for four weeks approximately 12 sessions to every subjects. First 30 minutes therapy consists of conventional therapy as given conventional tasks only with the affected upper extremity. 15 minutes were continued with mirror. Mirror is placed in front of the midline of the patient so that the affected limb is fully covered by the mirror and the reflection of the unaffected limb is fully visible. The affected limb positioned in a safe and comfortable position behind the mirror. The non-affected limb should be positioned in a similar position as the affected limb, as this facilitates the intensity of the mirror illusion. Patients in the experimental group received 45 minutes of consecutive session.

Locations

Country Name City State
Pakistan Sargodha Rafiqa Medical Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Chinnavan E, Ragupathy R, Wah YC. Effectiveness of mirror therapy on upper limb motor functions among hemiplegic patients. Bangladesh Journal of Medical Science. 2020;19(2): 208-13.

Dzhalagoniya I, Biryukova E, Bushkova Y, Kurganskaia M, Bobrov P, Frolov A. Biomechanical assessment of Fugl-Meyer score: the case of one post stroke patient who has undergone the rehabilitation using hand exoskeleton controlled by brain-computer interface. Int J Phys Med Rehabil. 2018;6(468):10.4172

Farooq A, Venketasubramanian N, Wasay M. Stroke Care in Pakistan. Cerebrovasc Dis Extra. 2021;11(3):118-121. doi: 10.1159/000519554. Epub 2021 Oct 25. — View Citation

Geller D, Nilsen DM, Quinn L, Van Lew S, Bayona C, Gillen G. Home mirror therapy: a randomized controlled pilot study comparing unimanual and bimanual mirror therapy for improved arm and hand function post-stroke. Disabil Rehabil. 2022 Nov;44(22):6766-6774. doi: 10.1080/09638288.2021.1973121. Epub 2021 Sep 19. — View Citation

Özkeskin M, Öztürk V, Çakmur R, Bilge K, Küçük F. The Effects of Navigated Repetitive Transcranial Magnetic Simulation and Brunnstrom Movement Therapy on Upper Extremity Proprioceptive Sense and Spasticity in Stroke Patients: A Double-Blind Randomized Trial. Journal of Basic and Clinical Health Sciences. 2017;1(2):29-35. .

Pandian S, Arya KN, Davidson EWR. Comparison of Brunnstrom movement therapy and Motor Relearning Program in rehabilitation of post-stroke hemiparetic hand: a randomized trial. J Bodyw Mov Ther. 2012 Jul;16(3):330-337. doi: 10.1016/j.jbmt.2011.11.002. Epub 2011 Dec 6. — View Citation

Pathan UHA, Thayyil AR, Juturu T, Kamath S, Pathan UHA. Pathophysiology, complications and management of stroke

Shahmoradi L, Almasi S, Ahmadi H, Bashiri A, Azadi T, Mirbagherie A, Ansari NN, Honarpishe R. Virtual reality games for rehabilitation of upper extremities in stroke patients. J Bodyw Mov Ther. 2021 Apr;26:113-122. doi: 10.1016/j.jbmt.2020.10.006. Epub 2020 Oct 11. — View Citation

Sharma N, Kumar N, Uniyal K. Intermittent Pneumatic Compression and Mirror Therapy Improve Hand Functions after Stroke. Physiotherapy and Occupational Therapy Journal. 2018;11(4):141-53

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer assessment wrist and hand (FMA-WH) subtest (item VII, VIII and IX), used as, item VII measures the wrist control; VIII measures the hand motor recovery (mass finger flexion, extension and grasp) and IX measures coordination of the movements. 4th week
Primary Brunnstrom Hand Manipulation (BRS-H) Brunnstrom Hand Manipulation (BRS-H) was used to determine motor recovery level of post-stroke patients. It consists of 6 hand stages. 4th Week
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