Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients

Effects of Modified Constraint Induced Movement Therapy (mCIMT) Versus Conservative Treatment on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients

"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: modified constraint induced movement therapy (mCIMT); Combination product: conservative treatment

Detailed Description

Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sialkot, Pakistan
    • Little angles home aziz bhati shaheed road opposit junior aps

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants will be under the age of 40-75 years
• Diagnosis: stroke

Exclusion Criteria:

• patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
• Balance problem
• Rheumatic diseases
• High spasticity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified constraint induced movement therapy (mCIMT)	Behavioral: modified constraint induced movement therapy (mCIMT); Restraint the involved extremity by using a mitten. Repetitive task practice i.e filling a glass, drinking a glass of water, and eating with a spoon , stacking cones and stacking blocks, grasping and releasing of an object, reaching forward and sideways, lifting and dropping of an object from the one end of table to the other end. The shaping exercises included cube stacking, card turning, throwing balls into a box, grasping/holding and placing objects of different sizes, and drawing and painting exercises. Intervention: 5 sessions per week for 50 minutes for 6 weeks
Experimental: conservative treatment	Combination product: conservative treatment; The conservative rehabilitation program consisted of upper-limb range of motion exercises, positioning, stretching, and strengthening exercises, Passive mobilization of the shoulder ,elbow , wrist and small joints of hand Stretching of the affected arm including biceps, triceps and muscles of forearm and hand. Strengthening exercises of upper arm and forearm muscles involved. Intervention: 5 sessions per week for six weeks and 50 mintues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthal index	Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency.	12 Months
The use of FMA-UE	measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities . In regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility. Every item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MSRSW/Batch-Fall22/733

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