Torticollis CongenitalNCT06015555
TAMO Therapy Versus Postural Control Exercise in Children With Congenital Muscular Torticollis
A study testing TAMO in people with Torticollis Congenital, run by khadija liaquat at 1 site in Pakistan.
Trial summary
A randomized control trial was conducted through convenient sampling. 18 subjects were randomly allocated into two groups, group A received postural control exercises in addition to conventional therapy, while Group B received TAMO therapy along with conventional therapy. analysis. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Torticollis Congenital
- What is being tested?
- TAMO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Greater than 3 months
- Both genders
- Abnormal neck posture
- Torticollis of both sides
Who cannot join
- SCM mass present
- Deficit in cervical PROM greater than 15 degree
- Craniosynostosis (it is a birth defect in which the bones in a baby skull join together too early)
- Infectious
- Metabolic
- Scoliosis of spine
Show all 9Show fewer
- Developmental plagiocephaly
- SCM tumor
- Visual disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Rehabilitation Center, Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effect Of Postural Control Exercise Versus¬¬ Tscharnuter Akademie For Motor Organization (TAMO) Therapy On Range Of Motion And Motor Function In Children With Congenital Muscular Torticollis
A randomized control trial was conducted through convenient sampling. 18 subjects were randomly allocated into two groups, group A received postural control exercises in addition to conventional therapy, while Group B received TAMO therapy along with conventional therapy. analysis.
Read the detailed description
Torticollis is common in children and can be congenital or acquired. Acquired cases can result from neck muscles or bone injuries. Though distressing for parents, it usually improves over time. Treatment includes postural control exercise and TAMO therapy, along with conventional treatment. To compare the effects of TAMO therapy versus postural control exercises on children with congenital muscular torticollis on cervical range of motion. A randomized control trial was conducted through convenient sampling. Eighteen subjects were randomly allocated into two groups; Group A received postural control exercises in addition to conventional therapy, while group B received TAMO therapy along with conventional therapy. The duration of the treatment was eight weeks. Goniometer, still photography, muscle function. Eighteen participants (n=18) were included in the study.
- Conditions
- Torticollis Congenital
- Being tested
- TAMO, Postural Control exercises
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAMOBehavioural
TAMO therapy
Postural Control exercisesBehavioural
Postural Control exercises
| Study group | Role | What they receive |
|---|---|---|
| The TAMO therapy | Experimental | For four months, TAMO therapy will last 30 minutes every day, twice a week. The therapist first applies light loading for a short period of time to his left hemiocciput directed toward the supporting surface. Receives: Behavioral: TAMO |
| Postural Control exercises | Experimental | For four months, posture control exercises will be taught twice a week for 30 minutes each time. Under the age of 3 months, infants were required to shift their chin as far to the affected side and upward in the supine or dominant prone posture before they could regulate their neck. Instead of passively adjusting the newborns' heads, we waited for them to actively turn toward their midline. Receives: Behavioral: Postural Control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
It measured cervical range of motion.
Measured: Readings were taken at baseline and four months of intervention
Muscle function Scale:
MFS is a tool used to check the function of the lateral flexors, a scale of 0 to 5, with higher scores indicating better function of muscles.Readings were taken at baseline and after four months of intervention of the neck in children,
Measured: Readings were taken at baseline and four months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start23 Feb 2023
- Primary completion25 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Torticollis CongenitalStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- khadija liaquat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khadija liaquat, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015555
- Sponsor's protocol ID
- RiphahIU- Farhan
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Postural Control Exercise Versus¬¬ Tscharnuter Akademie For Motor Organization (TAMO) Therapy On Range Of Motion And Motor Function In Children With Congenital Muscular Torticollis
- ClinicalTrials.gov ID
- NCT06015555
- Acronym / sponsor ID
- RiphahIU- Farhan
- Conditions
- Torticollis Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- khadija liaquatUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Aug 2023 (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.
A randomized control trial was conducted through convenient sampling. 18 subjects were randomly allocated into two groups, group A received postural control exercises in addition to conventional therapy, while Group B received TAMO therapy along with conventional therapy. analysis.
Detailed description
Torticollis is common in children and can be congenital or acquired. Acquired cases can result from neck muscles or bone injuries. Though distressing for parents, it usually improves over time. Treatment includes postural control exercise and TAMO therapy, along with conventional treatment. To compare the effects of TAMO therapy versus postural control exercises on children with congenital muscular torticollis on cervical range of motion. A randomized control trial was conducted through convenient sampling. Eighteen subjects were randomly allocated into two groups; Group A received postural control exercises in addition to conventional therapy, while group B received TAMO therapy along with conventional therapy. The duration of the treatment was eight weeks. Goniometer, still photography, muscle function. Eighteen participants (n=18) were included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TAMO therapy | Experimental | Behavioral: TAMOFor four months, TAMO therapy will last 30 minutes every day, twice a week. The therapist first applies light loading for a short period of time to his left hemiocciput directed toward the supporting surface. |
| Postural Control exercises | Experimental | Behavioral: Postural Control exercisesFor four months, posture control exercises will be taught twice a week for 30 minutes each time. Under the age of 3 months, infants were required to shift their chin as far to the affected side and upward in the supine or dominant prone posture before they could regulate their neck. Instead of passively adjusting the newborns' heads, we waited for them to actively turn toward their midline. |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Greater than 3 months
- Both genders
- Abnormal neck posture
- Torticollis of both sides
Key exclusion criteria (9 listed)
- SCM mass present
- Deficit in cervical PROM greater than 15 degree
- Craniosynostosis (it is a birth defect in which the bones in a baby skull join together too early)
- Infectious
- Metabolic
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 |
|---|---|---|
| TAMOTAMO therapy | Behavioural | The TAMO therapy |
| Postural Control exercisesPostural Control exercises | Behavioural | Postural Control exercises |
Primary outcome
Goniometer
Time frame: Readings were taken at baseline and four months of intervention
It measured cervical range of motion.
Muscle function Scale:
Time frame: Readings were taken at baseline and four months of intervention
MFS is a tool used to check the function of the lateral flexors, a scale of 0 to 5, with higher scores indicating better function of muscles.Readings were taken at baseline and after four months of intervention of the neck in children,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Enrolling by invitation
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAMO in people with Torticollis Congenital, run by khadija liaquat 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 29 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometer (time frame: Readings were taken at baseline and four months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2023.