NCT06015555

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 8, 2023

Last Update Submit

August 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Goniometer

    It measured cervical range of motion.

    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,

    Readings were taken at baseline and four months of intervention

Study Arms (2)

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.

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.

Behavioral: Postural Control exercises

Interventions

TAMOBEHAVIORAL

TAMO therapy

The TAMO therapy

Postural Control exercises

Postural Control exercises

Eligibility Criteria

Age3 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Greater than 3 months
  • Both genders
  • Abnormal neck posture
  • Torticollis of both sides

You may not qualify if:

  • 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
  • Developmental plagiocephaly
  • SCM tumor
  • Visual disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center, Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Congenital torticollis

Interventions

14-thioglycolamido-7,8-dihydromorphinone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 29, 2023

Study Start

February 23, 2023

Primary Completion

June 25, 2023

Study Completion

July 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations