- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598657
Talocrural Mobilization With Movement in Spastic Cerebral Palsy
Effects of Talocrural Joint Mobilization With Movement in Spastic Cerebral Palsy Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. It is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. In spastic CP, there is significant weakness that contributes to abnormal posture and movement. This is also accompanied by decreased muscle endurance and loss of selective motor control (SMC). Spastic diplegia is a very common form of CP, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. Abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with CP have in both static and dynamic balance.
Joint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments.
The Mulligan Mobilization with movement (MWM) is a physical therapy technique that combines joint mobilization techniques with active movement. It aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides.
This study will contribute in describing long lasting effects of Mobilization With Movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing MWM with conventional therapy and those with conventional therapy alone
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KINZA ANWAR, MS-OMPT
- Phone Number: +92-3239735427
- Email: kinza.anwar@riphah.edu.pk
Study Locations
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 46600
- Recruiting
- PAF School for Persons With special Needs PNS, Islamabad
-
Contact:
- KINZA ANWAR, MS-OMPT
- Phone Number: +92-3239735427
- Email: kinza.anwar@riphah.edu.pk
-
Contact:
- MAIMOONA MUBARIK, MS-OMPT*
-
Sub-Investigator:
- MAIMOONA MUBARIK, MS-OMPT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders
- Age group 8-18 years
- Diagnosis of spastic Cerebral Palsy
- CP to follow verbal directions
- Modified Ashworth Scale score of '1' or '1+'
- Function classification system (GMFCS) level I or II ability to walk
- 10 m or more independently
Exclusion Criteria:
- visual, hearing disorders
- verbal and cognitive disorders (unable to comprehend commands)
- recent lower extremity surgery
- botulinum toxin injection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mobilization with Movement MWM of Talocrural joint + Conventional PT
|
Mobilization with Movement MWM of Talocrural joint in non-weight bearing position to improve Dorsiflexion Range of Motion (3 sets of 6 repetitions were applied, with a 1-minute break between sets/3 times a week) and conventional therapy which includes stretching, strengthening, balance training exercise.
|
|
Other: Conventional PT
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goniometer
Time Frame: 4 weeks
|
It is an instrument that measures the available range of motion at a joint.
|
4 weeks
|
|
Time Up and Go
Time Frame: 4 weeks
|
In the TUG test, a child begins in a seated position on a chair or other designated surface.
They are instructed to stand up, walk a specific distance (usually three meters or ten feet), turn around, and return to the seated position.
The time taken to complete the task is recorded.
Evaluation is made by comparing pre and post-intervention.
To assess mobility of patient.
|
4 weeks
|
|
10 m WALK TEST
Time Frame: 4 weeks
|
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
It can be employed to determine functional mobility and gait.
Stopwatch is used and the total time taken to ambulate 6 meters is recorded.
Timing starts when the toes pass the 2-meter mark.
Timing stops when the toes pass the 8-meter mark.
The 6m is then divided by the total time taken (in seconds) to completed.
The total time is recorded in m/s
|
4 weeks
|
|
Modified Ashworth Scale (MAS)
Time Frame: 4 weeks
|
Modified Ashworth Scale (MAS) is used to assess spasticity.
Different grades from 0 to 4 are used to access increased tone and spasticity.
With 0 referring to "No increase in tone" and 4 refers to "Affected part rigid in flexion/extension" The measurements are recorded at baseline, during treatment and after treatment protocol.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: KINZA ANWAR, MS-OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01877 Maimoona Mubarik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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