NCT05392543

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

April 18, 2023

Conditions

Keywords

Brunnstorm movement therapyStrokeHemiplegiaMirror Therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

Brunnstrom movement therapy

Other: Brunnstrom movement therapy.

Group B

EXPERIMENTAL

Mirror therapy

Other: Mirror Therapy

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sargodha Rafiqa Medical Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 34695824BACKGROUND
  • 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

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

    BACKGROUND
  • 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.

    PMID: 22703742BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 34538193BACKGROUND
  • 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.

    PMID: 33992230BACKGROUND
  • 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

    BACKGROUND
  • 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. .

    BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Mehwish Ikram

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations