Autism Spectrum DisorderNCT06673732
Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With ASD
A study testing Muscle Energy Technique with Stationary Bi-Cyclying and Muscle Energy Technique without Stationary Cycling in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
In Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. People with ASD often have problems with social communication and interaction, and restricted or repetitive behaviors or interests. People with ASD may also have different ways of learning, moving, or paying attention. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Muscle Energy Technique with Stationary Bi-Cyclying and Muscle Energy Technique without Stationary Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Sep 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with diagnosed Autism .
- Aged between 4 to 10 years.
- Autistic children with Toe-Walking
- Regular for follow-up
- Both Gender included
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Lahore, Punjab Province, 54700
Imran Amjad, PhD
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With Autism Spectrum Disorder.
In Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. People with ASD often have problems with social communication and interaction, and restricted or repetitive behaviors or interests. People with ASD may also have different ways of learning, moving, or paying attention. The Aim of this thesis is Effects of Muscle Energy Technique with and without Stationary Cycling on toe walking children with Autism Spectrum Disorder This study seeks to explore whether the synergistic application of these interventions can provide a more comprehensive and effective approach in managing the debilitating symptoms associated with toe walking in Autistic children.
Read the detailed description
. The study\'s sample size will be 26 participants. Inclusion criteria for this study will be: Diagnosed Autistic between ages 4-10 years, Diagnosed Autistic Children, Treatment was given to each of the participants for 3 days a week and for 8 weeks. Inclusion criteria were all gender with the age group of 4-10 years, participants diagnosed cases of Autism spectrum disease with Toe Walking and their exclusion criteria were suspected but undiagnosed cases of ASD, the presence of any limb deformities , autistic children with MR, and unwillingness of participant or parents to be a part of the study. An RCT included 26 diagnosed autistic children as per inclusion criteria the subjects were divided into two groups, i.e., group A and B, the group A was given MET with Stationary bicycling whereas Group B was given MET without Stationary Bi-Cycling participants were clinically examined. Dynamometer, foot posture Index, Observational Gait Scale, and Parent report of percentage of time toe walking,
- Conditions
- Autism Spectrum Disorder
- Being tested
- Muscle Energy Technique with Stationary Bi-Cyclying, Muscle Energy Technique without Stationary Cycling
- Keywords
- Autism spectrum disorder, Muscle Energy Technique, Toe-walking, Stationary Cycling
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy Technique with Stationary Bi-CyclyingOther
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.
Muscle Energy Technique without Stationary CyclingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: Muscle Energy Technique without Stationary Cycling |
| Group B | Experimental | 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. Receives: Other: Muscle Energy Technique with Stationary Bi-Cyclying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational Gait Scale
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).
Measured: 8 weeks
Secondary outcomes (2)
foot Posture Index
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.
Measured: 5-10 minutes
Foot Dynamometer:
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start26 Sep 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rna Mohammad Iqbal, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673732
- Sponsor's protocol ID
- REC/RCR/AHS/24/Rna Iqbal
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.
PubMed 31949163
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06673732
- Acronym / sponsor ID
- REC/RCR/AHS/24/Rna Iqbal
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Muscle Energy Technique, Toe-walking, Stationary Cycling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. People with ASD often have problems with social communication and interaction, and restricted or repetitive behaviors or interests. People with ASD may also have different ways of learning, moving, or paying attention. The Aim of this thesis is Effects of Muscle Energy Technique with and without Stationary Cycling on toe walking children with Autism Spectrum Disorder This study seeks to explore whether the synergistic application of these interventions can provide a more comprehensive and effective approach in managing the debilitating symptoms associated with toe walking in Autistic children.
Detailed description
. The study\'s sample size will be 26 participants. Inclusion criteria for this study will be: Diagnosed Autistic between ages 4-10 years, Diagnosed Autistic Children, Treatment was given to each of the participants for 3 days a week and for 8 weeks. Inclusion criteria were all gender with the age group of 4-10 years, participants diagnosed cases of Autism spectrum disease with Toe Walking and their exclusion criteria were suspected but undiagnosed cases of ASD, the presence of any limb deformities , autistic children with MR, and unwillingness of participant or parents to be a part of the study. An RCT included 26 diagnosed autistic children as per inclusion criteria the subjects were divided into two groups, i.e., group A and B, the group A was given MET with Stationary bicycling whereas Group B was given MET without Stationary Bi-Cycling participants were clinically examined. Dynamometer, foot posture Index, Observational Gait Scale, and Parent report of percentage of time toe walking,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Muscle Energy Technique without Stationary CyclingGroup 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. |
| Group B | Experimental | Other: Muscle Energy Technique with Stationary Bi-CyclyingGroup 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. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with diagnosed Autism .
- Aged between 4 to 10 years.
- Autistic children with Toe-Walking
- Regular for follow-up
- Both Gender included
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Energy Technique with Stationary Bi-CyclyingMET 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. | Other | Group B |
| Muscle Energy Technique without Stationary CyclingMET 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 | Other | Group A |
Primary outcome
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).
2 secondary outcomes
foot Posture Index
Time frame: 5-10 minutes
Foot Dynamometer:
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 31949163Lord C, Brugha TS, Charman T, Cusack J, Dumas G, Frazier T, Jones EJH, Jones RM, Pickles A, State MW, Taylor JL, Veenstra-VanderWeele J. Autism spectrum disorder. Nat Rev Dis Primers. 2020 Jan 16;6(1):5. doi: 10.1038/s41572-019-0138-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rna Mohammad Iqbal, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique with Stationary Bi-Cyclying and Muscle Energy Technique without Stationary Cycling in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational Gait Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06673732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.