- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673732
Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With ASD
Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With Autism Spectrum Disorder.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Recruiting
- Riphah International University
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
-
Contact:
- Imran Amjad, PhD
-
Principal Investigator:
- Rna Mohammad Iqbal, MS*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with diagnosed Autism .
- Aged between 4 to 10 years.
- Autistic children with Toe-Walking
- Regular for follow-up
- Both Gender included
Exclusion Criteria:
- Children with Comorbidities .
- Children with mild cognitive dysfunction
- Children less then 4 year or older than 10 years..
- Autistic Children with limb deformity
- Autistic Children with Mental Retardation.
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 |
|---|---|
|
Experimental: Group A
Group A (n=14) will receive Muscle Energy Technique (MET) combined with stationary Cycling.
In the first three days, an initial assessment will be conducted, including Visual Gait Analysis, the Observational Gait Scale, and the Foot Posture Index.
From Week 1 to 4, MET will involve the patient contracting for 5-10 seconds while the therapist resists, followed by a rapid 10-second stretch (3-5 repetitions), along with stationary Cycling for 5-10 minutes.
A follow-up assessment will occur in Week 4. From Week 5 to 8, the same protocol will continue with 5-8 repetitions and cycling for 10-20 minutes, concluding with a final assessment in Week 8.
|
MET for post-isometric relaxation of the Achilles, calf, quads, hamstrings, and ankle, position each muscle at resistance, just short of pain.
The patient contracts (10-20% effort) for 5-10 seconds while the therapist resists.
After relaxing and exhaling, the therapist gently stretches the muscle to the new barrier.
Repeat this process 2-3 times, gradually increasing the stretch with each repetition.
Post FS MET of the Achilles tendon, calf, quads, hamstrings, and ankle, contract the muscle maximally for 5-10 seconds while the therapist resists.
Afterward, the muscle is relaxed, and the therapist quickly stretches it to the new barrier, holding for 10 seconds.
Following a 20-second rest, repeat the process 3-5 times.
For Reciprocal Inhibition MET, the muscle is placed mid-range, the patient pushes against resistance, then relaxes while the therapist stretches the muscle.
This is repeated 3-5 times without Stationary Cycling
|
|
Experimental: Group B
Group B (n=14) will undergo Muscle Energy Technique without stationary cycling.
In the first 3 days, an initial assessment, including Visual Gait Analysis, Observational Gait Scale, and Foot Posture Index, will be conducted.
From Week 1 to 4, the technique involves the patient contracting for 5-10 seconds while the therapist resists, followed by a rapid 10-second stretch (3-5 repetitions).
A follow-up assessment will occur in Week 4. From Week 5 to 8, the same process continues with 5-8 repetitions, ending with a final assessment in Week 8.
|
MET for post-isometric relaxation of the Achilles, calf, quads, hamstrings, and ankle, position each muscle at resistance, just short of pain. The patient contracts (10-20% effort) for 5-10 seconds while the therapist resists. After relaxing and exhaling, the therapist gently stretches the muscle to the new barrier. Repeat this process 2-3 times, gradually increasing the stretch with each repetition. For PFS MET of the Achilles tendon, calf, quads, hamstrings, and ankle, contract the muscle maximally for 5-10 seconds while the therapist resists. Afterward, the muscle is relaxed, and the therapist quickly stretches it to the new barrier, holding for 10 seconds. Following a 20-second rest, repeat the process 3-5 times. For Reciprocal Inhibition MET, the muscle is placed mid-range, the patient pushes against resistance, then relaxes while the therapist stretches the muscle. This is repeated 3-5 times. Stationary cycling complements the routine. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observational Gait Scale
Time Frame: 8 weeks
|
Observational Gait Scale An Assessment/observational gait exam is the Observational Gait Scale (OGS).
The OGS is primarily used to rate gait metrics using a structured scale from video recordings It focuses on the knee joint and foot position during mid-stance. .
In routine clinical practice, observational gait evaluation is regarded as a more economical option to IGA.
The purpose of this paper is to evaluate the validity and reliability of the various pediatric gait analysis techniques by doing a thorough evaluation and comparing them to IGA.(20)
The OGS score's validity was assessed by contrasting it with the 3-DGA.
For knee and foot posture in mid-stance, first foot contact, and heel rise, the OGS was shown to have satisfactory interrater and intrarater reliability with weighted kappas (wk) ranging from 0.53 to 0.91 (intrarater) and 0.43 to 0.86 (interrater).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
foot Posture Index
Time Frame: 5-10 minutes
|
The Foot Posture Index (FPI) assesses foot alignment using six criteria, including talar head position, arch height, and heel alignment.
Each criterion is scored from -2 to +2, indicating levels of supination (negative) or pronation (positive).
The total score classifies the foot as supinated, neutral, or pronated.
It's a useful tool for identifying foot posture and potential biomechanical issues.
|
5-10 minutes
|
|
Foot Dynamometer:
Time Frame: 8 weeks
|
A foot dynamometer is a device used to measure the strength and force exerted by the foot muscles.
It assesses grip strength, particularly in the toes, and is often used in sports science and rehabilitation to evaluate foot function, stability, and recovery progress.
The dynamometer provides objective data on muscle force, which helps guide therapy for foot injuries or biomechanical issues
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rna Mohammad Iqbal, MS*, Riphah International University
Publications and helpful links
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
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/RCR/AHS/24/Rna Iqbal
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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