NCT06762249

Brief Summary

Stroke is a leading cause of disability characterized by inadequate blood supply to the brain, leading to cell death and neurological deficits. Motor impairment of the upper extremity is a common consequence among stroke patients, resulting in paralysis of the upper limb. Both Constraint Induced Movement Therapy and Brunnstrom therapy have shown promise in improving motor activity and overall quality of life in stroke patients.This randomized controlled trial will be carried out at in Multan over 10 months. Total number of 56 participants meeting the inclusion criteria will be included in this study. Participants will be randomly assigned into 2 groups . Both groups will receive interventions for five days a week for 4 weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Keywords

Brunnstrom movement therapyConstraint induced movement therapymotor activityquality of lifespacticitystroke patients

Outcome Measures

Primary Outcomes (4)

  • Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)

    The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal"

    4 weeks

  • Functional Independence Measure (FIM)

    The scale consists of six sub-headings and a total of 18 items. Scores that can be obtained from the scale range from 18-126, and higher scores indicate that the individual is more independent in daily life

    4 weeks

  • Modified Ashworth scale

    The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.

    4 weeks

  • Mini Mental state examination

    The MMSE is a widely used cognition screening test. It has a maximum score of 30 points. It assesses aspects of orientation, recall, language and visual construction.

    4 weeks

Study Arms (2)

CIMT+ Brunnstrom therapy + routine physical therapy.

EXPERIMENTAL

Group A participants will receive Constraints innduced movement therapy and Brunnstrom movement therapy along with routine physical therapy This therapy will be given as 5 days session for 4 weeks.

Other: CIMT + Brunnstrom therapy + routine physical therapy

CIMT + routine physical therapy

ACTIVE COMPARATOR

Group B participants will receive Constraint Induced movement therapy along with routine physical therapy exercises. This therapy will be given for 4 weeks.

Other: CIMT + routine physical therapy

Interventions

this therapy will be given for 5 days per week for 4 weeks.

CIMT+ Brunnstrom therapy + routine physical therapy.

this therapy will be given for 5 days per week for 4 weeks

CIMT + routine physical therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group between 40 and 70 years
  • Both male and female
  • Patient being diagnosed with hemiplegic stroke
  • Patient having hemorrhagic stroke or ischemic stroke
  • Patient able to give their consent for rehabilitation program
  • Patient having 24 or higher score from Standardized Mini-Mental Test
  • Patient being able to stand for 2 min without assistance from a person

You may not qualify if:

  • Patient with cognitive impairment or dementia
  • Patient having any other disease that prevents participation in the rehabilitation program
  • Patient that participated in any ongoing rehabilitation program
  • Patient having pain in UE 4 or higher according to the Visual Analog Scale which is scored 0-10
  • Patient had spasticity in any joint of the UE and scored 2 or higher according to the Modified Ashworth Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azeem Electroneurophysiology diognostic and Physiotherapy center Multan

Multan, Punjab Province, Pakistan

Location

Qaisrani Hospital Multan

Multan, Punjab Province, Pakistan

Location

Related Publications (8)

  • Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraintinduced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5.

    BACKGROUND
  • . Shaheen S, Afzal B, Tahir M, Mahmood U, Yousaf F, Tariq F. Combined Effects of Brunnstorm Movement Therapy and Low-Level Laser Therapy on Upper Limb Function and Hand Dexterity in Chronic Stroke Patient. Journal of Health and Rehabilitation Research. 2024;4(1):1457-62

    BACKGROUND
  • Rocha LSO, Gama GCB, Rocha RSB, Rocha LB, Dias CP, Santos LLS, Santos MCS, Montebelo MIL, Teodori RM. Constraint Induced Movement Therapy Increases Functionality and Quality of Life after Stroke. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105774. doi: 10.1016/j.jstrokecerebrovasdis.2021.105774. Epub 2021 Apr 10.

    PMID: 33848906BACKGROUND
  • Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021.

    PMID: 34366819BACKGROUND
  • Nasb M, Li Z, S A Youssef A, Dayoub L, Chen H. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019 Dec;14(1):1609304. doi: 10.1080/19932820.2019.1609304.

    PMID: 31032717BACKGROUND
  • Puri S, Kovela RK, Qureshi MI, Dadgal R, Timothy R, Samal S. Effect of Brunnstrom Movement Therapy Combined with Neurodevelopmental Therapy on Balance and Mobility in a Patient with Acute Stroke: An Interesting Case Report. JPRI. 2022:6-9.

    BACKGROUND
  • Dhanalakshmi L, Alagesan J, Buvanesh A. Effectiveness of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Upper Extremity Functions in Stroke. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.

    BACKGROUND
  • Akter R, Sharma N, Ahmed S, Srivastav AK. Combined effect of Brunnstrom's hand rehabilitation and functional electrical stimulation for improving hand function in patients with chronic stroke: A randomized controlled trial. J Bodyw Mov Ther. 2023 Jul;35:84-90. doi: 10.1016/j.jbmt.2023.04.021. Epub 2023 Apr 28.

    PMID: 37330808BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sabiha Arshad

    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
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

October 1, 2024

Primary Completion

February 1, 2025

Study Completion

May 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations