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Clinical Trials/NCT06548295
NCT06548295
Active, not recruiting
Not Applicable

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

Superior University1 site in 1 country26 target enrollmentOctober 1, 2023
ConditionsChronic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
Superior University
Enrollment
26
Locations
1
Primary Endpoint
Barthal index
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

"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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Barthal index

Time Frame: 12 Months

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.

The use of FMA-UE

Time Frame: 12 months

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

Study Sites (1)

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