Comparison Between the Efficacy of CIMT and NDT Along With Conventional Physiotherapy Treatment on Upper Extremity Rehabilitation Among Patients of Stroke (CIMT)

To compare the efficacy of CIMT and NDT among stroke patients To study the phenomena of transfer of training To study relationship between the MMSE score and stroke rehabilitation

Study Overview

• Status: Not yet recruiting
• Conditions: Strokes Thrombotic
• Intervention / Treatment: Other: Constraint-induced movement therapy; Other: Neurodevelopmental Treatment

Detailed Description

This research aims to provide a comprehensive comparison of CIMT and NDT, supplemented by conventional physiotherapy, in the rehabilitation of upper extremity function among stroke patients. The findings will inform clinical practice, guiding the development of optimized, patient-centered rehabilitation strategies.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Ayesha Fatima
      • Contact: JAVERIYA ASLAM; Phone Number: 03119353656
      • Contact: MASOOMA GULL; Phone Number: 03244283378; Email: masoomagull2@ymail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 23.

Exclusion Criteria:

• Participants with visual or auditory deficits, musculoskeletal (MSK) disorders, mental impairments, or a history of surgery will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Constraint-Induced Movement Therapy; The rehabilitation plan involves several components to promote the recovery of the affected limb. Initially, we will immobilize the unaffected limb using a constraint device such as a mitt or sling for about 90% of waking hours over a period of six weeks.	Other: Constraint-induced movement therapy; is a rehabilitation technique used to improve motor function in people who have had a stroke or other neurological conditions. CIMT restricts the use of the unaffected limb, typically with a mitt or sling, to encourage the use of the affected limb.
Other: neurodevelopmental treatment; The rehabilitation approach includes hands-on techniques to guide the patient through normal movement patterns. By providing sensory input, we aim to improve motor control and postural alignment, using techniques such as handling, guiding, and assisting movements.	Other: Neurodevelopmental Treatment; Therapy, is a rehabilitation approach used to address movement and motor control deficits in people with neurological illnesses such as stroke, cerebral palsy, or traumatic brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper extremity rehabilitation	The Motor Assessment Scale (MAS) by Carr and Shepherd is a clinical tool used to evaluate upper extremity rehabilitation in stroke patients. It assesses motor recovery through eight items, each reflecting daily activities, scored on a 7-point scale from 0 (unable to perform) to 6 (optimal performance). For upper extremity assessment, the MAS includes tasks like hand movements (grasping, releasing, manipulating objects), advanced hand activities (fine motor skills such as writing or buttoning a shirt), and upper arm function (reaching, lifting, placing objects). Patients perform these tasks while clinicians observe and score their performance. The MAS provides a quantitative measure of motor recovery, facilitating progress tracking, goal setting, and personalized therapy interventions, making it a reliable and straightforward tool for capturing functional changes in stroke patients.	6 WEEKS

Collaborators and Investigators

• Sponsor: Shalamar Institute of Health Sciences

Publications and helpful links

General Publications

• 1. Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. The Lancet Neurology. 201514(2):224-34. 2. Uswatte G, Taub E. Constraint-induced movement therapy: a method for harnessing neuroplasticity to Page 5 of 7 treat motor disorders. Progress in brain research. 2013207:379-401. 3. Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, et al. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Frontiers in neurology. 202112:622014. 4. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research. 197512(3):189-98. 5. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 198767(2):206-7. 6. Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 198565(2):175-80. 7. Ahn SY, Bok S-K, Lee JY, Ryoo HW, Lee HY, Park HJ, et al. Benefits of Robot-Assisted Upper-Limb Rehabilitation from the Subacute Stage after a Stroke of Varying Severity: A Multicenter Randomized Controlled Trial. Journal of Clinical Medicine. 202413(3):808. 8. Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, et al. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016315(6):571-81. 9. Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia. Developmental medicine and child neurology. 201153(4):313-20.

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2024
• Primary Completion (Estimated): November 29, 2024
• Study Completion (Estimated): January 29, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: (CIMT); (NDT)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemic Stroke; Stroke; Thrombotic Stroke
• Other Study ID Numbers: ShalamarIHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No