Congenital Muscular TorticollisNCT02824848
Perception-Action Approach vs. Passive Stretching for Infants With Congenital Muscular Torticollis
A study testing Passive Stretching and Perception-Action Approach in people with Congenital Muscular Torticollis, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
Trial summary
Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Congenital Muscular Torticollis
- What is being tested?
- Passive Stretching and Perception-Action Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2016to 6 May 2020
- 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 Up to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between birth and 9 months at the time of recruitment
- diagnosis of congenital muscular torticollis as documented in the medical record
- Parents agree not to have their child participate in any additional interventions for CMT during the course of the study
Who cannot join
- other types of torticollis, such as neuromuscular torticollis, Sandifer syndrome, benign paroxysmal torticollis, ocular torticollis and other non-muscular types of torticollis, such as related to bony anomalies, which would warrant a referral back to the referring physician or to an appropriate specialist for diagnosis
- being seen for torticollis by another health care provider
- parents were using passive stretching with their infant prior to the study being offered to them AND would like to continue with passive stretching, but the child is assigned to the other intervention group
- parents were using Perception-Action Approach with their infant prior to the study being offered to them AND would like to continue with the same approach but the child is assigned to the other intervention group
- the child is found to meet the exclusion criteria at any time during the clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital, San Diego
San Diego, California, 92123
About this study
Official title: Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial
Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. In this randomized clinical trial, researchers will compare two physical therapy (PT) treatment methods, passive stretching and Perception-Action (P-A) Approach, in their effects on head position and use of both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly assigned to a passive stretching group or a P-A Approach group. The infants in both groups will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head position, the ability to turn the head to both sides, muscle strength on both sides of the neck, motor development, and use of both sides of the body for movement and play will be assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4. Results obtained from the two groups will be compared.
It is hypothesized that:
- There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:
- Still photography
- Arthrodial goniometry used to assess active head rotation to both sides
- The Muscle Function Scale (MFS) used to assess neck muscle strength
- The Alberta Infant Motor Scale (AIMS) used to assess motor development
- There will be no significant difference between the groups on the above listed measures after the intervention is completed.
- The P-A Approach group will achieve greater gains than the passive stretching group between the initial and final assessments on the Functional Symmetry Observation Scale (FSOS) used to assess the use of both sides of the body for movement and play
- The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than the passive stretching group assigned based on participants' behavior demonstrated during PT intervention sessions
Read the detailed description
This prospective longitudinal study will be a two-group, single-blind, pre-post-test design randomized clinical trial (RCT). The purpose of this study will be two-fold:
- To compare the efficacy of passive stretching and Perception-Action (P-A) Approach interventions in improving postural alignment, symmetrical use of both sides of the body during movement and play, and gross motor development in infants with congenital muscular torticollis (CMT)
- To compare therapy-related behavior in infants with CMT undergoing passive stretching and P-A Approach interventions during physical therapy (PT) sessions
Within group comparisons will be made to assess change over time, and between group comparisons will be made to compare the effects of the two interventions. Both interventions are used in the clinic for infants with CMT but it is not known whether they are equally effective or if one is more effective than the other.
Thirty-six consecutively enrolled infants with CMT will be randomly assigned to a Passive Stretching group or a P-A Approach group using a blocked randomization procedure. Each infant will attend 5 weekly 60-minute PT sessions, including the initial evaluation, 3 interventions sessions, and a re-evaluation. The total duration of each participant's involvement in the study will be approximately 1-2 months. At visits 1 and 5, each infant's habitual head deviation from midline, active head rotation to both sides, neck muscle strength on both sides, motor development, and symmetrical use both sides of the body for movement and play will be assessed.
Participants' photos will be taken in a supine position and parts of the initial PT evaluation and re-evaluation sessions will be video recorded for future analyses by an assessor blind to the infants' group assignment. Such analyses will include still photography measurements, assessment of motor development using the Alberta Infant Motor Scale (AIMS), and assessment of symmetrical use of both sides of the body using the Functional Symmetry Observation Scale (FSOS). Treating therapists will perform "live" active head rotation and muscle strength measurements, for which assessor blinding will not be possible. In addition, each infant's behavior exhibited during therapy will be assessed by the treating therapist at intervention sessions 2-4. Results obtained from the two groups will be compared.
At the first PT visit, the treating therapist will conduct a PT evaluation, educate the caregiver in proper positioning and benefits of tummy time, and provide intervention specific to the infant's group assignment. For the Passive Stretching Group, intervention will include caregiver instruction in passive stretching for lateral flexion and rotation of the neck, with the parent practicing the techniques. For the P-A Approach Group, intervention will include the interpretation of the infant's behavior for the caregiver while manual guidance is provided to the infant. At 3 subsequent PT sessions, group-specific intervention and continued caregiver instruction will be provided. Passive Stretching Group intervention components will include passive stretching and associated strengthening activities. P-A Approach Group intervention components will include environmental set-up and manual guidance. At the final PT visit in the study, a PT re-evaluation will be conducted, followed by group-specific intervention as needed.
Prior to initiating the RCT, a pilot study will be conducted to establish the intrarater, test-retest or inter-rater reliability of the outcome measures, as appropriate. A total of 10 infants with CMT will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a Fidelity of Intervention Checklist to ensure the treating therapists' adherence to the strategies outlined as essential elements of each of the intervention approaches. In addition, during the main study, intervention adherence will be assessed by tracking the participants' attendance, the PT session length and frequency, and the total duration of each subject's research participation.
- Conditions
- Congenital Muscular Torticollis
- Being tested
- Passive Stretching, Perception-Action Approach
- Keywords
- congenital muscular torticollis, infants, passive stretching, perception-action approach
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive StretchingBehavioural
Also called Passive movement, physical therapy
Passive stretching and associated strengthening activities to change head/neck and body alignment
Perception-Action ApproachBehavioural
Also called Perceptual-motor intervention, physical therapy
Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities
| Study group | Role | What they receive |
|---|---|---|
| Passive Stretching | Active comparator | Passive Stretching intervention components include static passive stretching, active assistive range of motion, assisted stretching of the involved cervical musculature, and associated strengthening activities aimed to elicit head righting in developmentally appropriate positions and during developmentally appropriate movement transitions. Intervention is progressed by increasing head tilt angles, duration of head righting, and frequency and number of repetitions. Receives: Behavioral: Passive Stretching |
| Perception-Action Approach | Active comparator | P-A Approach intervention components include environmental set-up for activity and participation in play, and manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions. Both components are designed to promote spontaneous exploration of the environment by the infant by suggesting small, incremental changes in his/her perceptual-motor orientation and contact with the support surface. Intervention is progressed by gradually removing environmental supports provided to the infant's body parts, and by removing the therapist's hands from the infant's body to allow for spontaneous exploration of a newly found contact with the support surface or new body configuration. Receives: Behavioral: Perception-Action Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Still Photography
Change in the angle of habitual head deviation from midline assessed in a supine position
Measured: At baseline and week 5
Arthrodial Goniometry
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Measured: At baseline and week 5
Muscle Function Scale (MFS)
Change in the MFS score that reflects the difference in strength of lateral neck flexor muscles during head righting between the involved and uninvolved sides
Measured: At baseline and week 5
Functional Symmetry Observation Scale (FSOS)
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
Measured: At baseline and week 5
Alberta Infant Motor Scale (AIMS)
Change in the AIMS score that reflects gross motor development while also considering symmetrical postural alignment and symmetrical use of both sides of the body during movement and play
Measured: At baseline and week 5
Secondary outcomes (1)
Therapy Behavior Scale (TBS)
The TBS score documents therapy-related behavior during intervention sessions; to be used for between group comparison only.
Measured: Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start4 Aug 2016
- Primary completion2 Mar 2020
- Study completion6 May 2020
Why it stopped: Study stopped due to COVID-19 pandemic and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Muscular TorticollisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, Mary Rahlin, Rosalind Franklin University of Medicine and Science
- Investigators
- Mary Rahlin, PT, DHS, PCS, Principal investigator, Rosalind Franklin University of Medicine and ScienceNancy Haney, PT, MS, Principal investigator, Rady Children' Hospital, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824848
- Sponsor's protocol ID
- 421 PT
- Other IDs
- 160161
- Status last verified
- May 2020
- First submitted
- 2 Jul 2016
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Kaplan SL, Coulter C, Fetters L. Physical therapy management of congenital muscular torticollis: an evidence-based clinical practice guideline: from the Section on Pediatrics of the American Physical Therapy Association. Pediatr Phys Ther. 2013 Winter;25(4):348-94. doi: 10.1097/PEP.0b013e3182a778d2.
PubMed 24076627Rahlin M. TAMO therapy as a major component of physical therapy intervention for an infant with congenital muscular torticollis: a case report. Pediatr Phys Ther. 2005 Fall;17(3):209-18. doi: 10.1097/01.pep.0000179176.20035.f0.
PubMed 16357675Cheng JC, Chen TM, Tang SP, Shum SL, Wong MW, Metreweli C. Snapping during manual stretching in congenital muscular torticollis. Clin Orthop Relat Res. 2001 Mar;(384):237-44. doi: 10.1097/00003086-200103000-00028.
PubMed 11249171Tscharnuter I. Clinical Application of Dynamic Theory Concepts According to Tscharnuter Akademie for Movement Organization (TAMO) Therapy. Pediatr Phys Ther. 2002 Spring;14(1):29-37.
PubMed 17053679Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.
PubMed 21145518Rahlin M, Sarmiento B. Reliability of still photography measuring habitual head deviation from midline in infants with congenital muscular torticollis. Pediatr Phys Ther. 2010 Winter;22(4):399-406. doi: 10.1097/PEP.0b013e3181f9d72d.
PubMed 21068640Blanchard Y, Neilan E, Busanich J, Garavuso L, Klimas D. Interrater reliability of early intervention providers scoring the alberta infant motor scale. Pediatr Phys Ther. 2004 Spring;16(1):13-8. doi: 10.1097/01.PEP.0000113272.34023.56.
PubMed 17057466Rahlin M, McCloy C, Henderson R, Long T, Rheault W. Development and content validity of the Therapy Behavior Scale. Infant Behav Dev. 2012 Jun;35(3):452-65. doi: 10.1016/j.infbeh.2012.03.001. Epub 2012 Jun 26.
PubMed 22729134Rahlin M, Haney NB, Barnett J. Perception-Action Approach Versus Standard Care for Infants With Congenital Muscular Torticollis: A Pilot Single-Blind Randomized Controlled Trial. Phys Ther. 2024 Apr 2;104(4):pzae038. doi: 10.1093/ptj/pzae038.
PubMed 38484092
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perception-Action Approach and Passive Stretching Interventions for Infants With Congenital Muscular Torticollis: A Single-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02824848
- Acronym / sponsor ID
- 421 PT
- Conditions
- Congenital Muscular Torticollis
- Keywords
- congenital muscular torticollis, infants, passive stretching, perception-action approach
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to COVID-19 pandemic and will not resume.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 7 Jul 2016 (estimated)
- 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.
Congenital muscular torticollis (CMT) results from tightness of neck musculature that causes the infant to tilt the head to one side and turn it to the other side. Infants with CMT also show unequal use of both sides of the body for movement and play. In this randomized clinical trial, researchers will compare two physical therapy (PT) treatment methods, passive stretching and Perception-Action (P-A) Approach, in their effects on head position and use of both sides of the body in infants with CMT. Behavior demonstrated during PT sessions by infants in the two groups will be also compared. Thirty-six infants with CMT will be randomly assigned to a passive stretching group or a P-A Approach group. The infants in both groups will attend 5 weekly PT sessions, including the initial evaluation, 3 subsequent weekly sessions, and a re-evaluation session. At visits 1 and 5, each infant's habitual head position, the ability to turn the head to both sides, muscle strength on both sides of the neck, motor development, and use of both sides of the body for movement and play will be assessed. Each infant's behavior exhibited during therapy will be assessed at visits 2-4. Results obtained from the two groups will be compared.
It is hypothesized that:
- There will be significant gains achieved by both intervention groups between the initial and final assessments on the following outcome measures:
- Still photography
- Arthrodial goniometry used to assess active head rotation to both sides
- The Muscle Function Scale (MFS) used to assess neck muscle strength
- The Alberta Infant Motor Scale (AIMS) used to assess motor development
- There will be no significant difference between the groups on the above listed measures after the intervention is completed.
- The P-A Approach group will achieve greater gains than the passive stretching group between the initial and final assessments on the Functional Symmetry Observation Scale (FSOS) used to assess the use of both sides of the body for movement and play
- The P-A Approach group will demonstrate higher Therapy Behavior Scale (TBS) scores than the passive stretching group assigned based on participants' behavior demonstrated during PT intervention sessions
Detailed description
This prospective longitudinal study will be a two-group, single-blind, pre-post-test design randomized clinical trial (RCT). The purpose of this study will be two-fold:
- To compare the efficacy of passive stretching and Perception-Action (P-A) Approach interventions in improving postural alignment, symmetrical use of both sides of the body during movement and play, and gross motor development in infants with congenital muscular torticollis (CMT)
- To compare therapy-related behavior in infants with CMT undergoing passive stretching and P-A Approach interventions during physical therapy (PT) sessions
Within group comparisons will be made to assess change over time, and between group comparisons will be made to compare the effects of the two interventions. Both interventions are used in the clinic for infants with CMT but it is not known whether they are equally effective or if one is more effective than the other.
Thirty-six consecutively enrolled infants with CMT will be randomly assigned to a Passive Stretching group or a P-A Approach group using a blocked randomization procedure. Each infant will attend 5 weekly 60-minute PT sessions, including the initial evaluation, 3 interventions sessions, and a re-evaluation. The total duration of each participant's involvement in the study will be approximately 1-2 months. At visits 1 and 5, each infant's habitual head deviation from midline, active head rotation to both sides, neck muscle strength on both sides, motor development, and symmetrical use both sides of the body for movement and play will be assessed.
Participants' photos will be taken in a supine position and parts of the initial PT evaluation and re-evaluation sessions will be video recorded for future analyses by an assessor blind to the infants' group assignment. Such analyses will include still photography measurements, assessment of motor development using the Alberta Infant Motor Scale (AIMS), and assessment of symmetrical use of both sides of the body using the Functional Symmetry Observation Scale (FSOS). Treating therapists will perform "live" active head rotation and muscle strength measurements, for which assessor blinding will not be possible. In addition, each infant's behavior exhibited during therapy will be assessed by the treating therapist at intervention sessions 2-4. Results obtained from the two groups will be compared.
At the first PT visit, the treating therapist will conduct a PT evaluation, educate the caregiver in proper positioning and benefits of tummy time, and provide intervention specific to the infant's group assignment. For the Passive Stretching Group, intervention will include caregiver instruction in passive stretching for lateral flexion and rotation of the neck, with the parent practicing the techniques. For the P-A Approach Group, intervention will include the interpretation of the infant's behavior for the caregiver while manual guidance is provided to the infant. At 3 subsequent PT sessions, group-specific intervention and continued caregiver instruction will be provided. Passive Stretching Group intervention components will include passive stretching and associated strengthening activities. P-A Approach Group intervention components will include environmental set-up and manual guidance. At the final PT visit in the study, a PT re-evaluation will be conducted, followed by group-specific intervention as needed.
Prior to initiating the RCT, a pilot study will be conducted to establish the intrarater, test-retest or inter-rater reliability of the outcome measures, as appropriate. A total of 10 infants with CMT will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a Fidelity of Intervention Checklist to ensure the treating therapists' adherence to the strategies outlined as essential elements of each of the intervention approaches. In addition, during the main study, intervention adherence will be assessed by tracking the participants' attendance, the PT session length and frequency, and the total duration of each subject's research participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Stretching | Active comparator | Behavioral: Passive StretchingPassive Stretching intervention components include static passive stretching, active assistive range of motion, assisted stretching of the involved cervical musculature, and associated strengthening activities aimed to elicit head righting in developmentally appropriate positions and during developmentally appropriate movement transitions. Intervention is progressed by increasing head tilt angles, duration of head righting, and frequency and number of repetitions. |
| Perception-Action Approach | Active comparator | Behavioral: Perception-Action ApproachP-A Approach intervention components include environmental set-up for activity and participation in play, and manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions. Both components are designed to promote spontaneous exploration of the environment by the infant by suggesting small, incremental changes in his/her perceptual-motor orientation and contact with the support surface. Intervention is progressed by gradually removing environmental supports provided to the infant's body parts, and by removing the therapist's hands from the infant's body to allow for spontaneous exploration of a newly found contact with the support surface or new body configuration. |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between birth and 9 months at the time of recruitment
- diagnosis of congenital muscular torticollis as documented in the medical record
- Parents agree not to have their child participate in any additional interventions for CMT during the course of the study
Key exclusion criteria (5 listed)
- other types of torticollis, such as neuromuscular torticollis, Sandifer syndrome, benign paroxysmal torticollis, ocular torticollis and other non-muscular types of torticollis, such as related to bony anomalies, which would warrant a referral back to the referring physician or to an appropriate specialist for diagnosis
- being seen for torticollis by another health care provider
- parents were using passive stretching with their infant prior to the study being offered to them AND would like to continue with passive stretching, but the child is assigned to the other intervention group
- parents were using Perception-Action Approach with their infant prior to the study being offered to them AND would like to continue with the same approach but the child is assigned to the other intervention group
- the child is found to meet the exclusion criteria at any time during the clinical trial
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 |
|---|---|---|
| Passive StretchingAlso: Passive movement, physical therapyPassive stretching and associated strengthening activities to change head/neck and body alignment | Behavioural | Passive Stretching |
| Perception-Action ApproachAlso: Perceptual-motor intervention, physical therapyEnvironmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities | Behavioural | Perception-Action Approach |
Primary outcome
Still Photography
Time frame: At baseline and week 5
Change in the angle of habitual head deviation from midline assessed in a supine position
Arthrodial Goniometry
Time frame: At baseline and week 5
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Muscle Function Scale (MFS)
Time frame: At baseline and week 5
Change in the MFS score that reflects the difference in strength of lateral neck flexor muscles during head righting between the involved and uninvolved sides
Functional Symmetry Observation Scale (FSOS)
Time frame: At baseline and week 5
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
Alberta Infant Motor Scale (AIMS)
Time frame: At baseline and week 5
Change in the AIMS score that reflects gross motor development while also considering symmetrical postural alignment and symmetrical use of both sides of the body during movement and play
1 secondary outcome
Therapy Behavior Scale (TBS)
Time frame: Weeks 2, 3 and 4 (at the time of intervention sessions 2, 3 and 4)
Results and safety
The study was stopped early (reason given: Study stopped due to COVID-19 pandemic and will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 24076627Kaplan SL, Coulter C, Fetters L. Physical therapy management of congenital muscular torticollis: an evidence-based clinical practice guideline: from the Section on Pediatrics of the American Physical Therapy Association. Pediatr Phys Ther. 2013 Winter;25(4):348-94. doi: 10.1097/PEP.0b013e3182a778d2.
- Background: PubMed 16357675Rahlin M. TAMO therapy as a major component of physical therapy intervention for an infant with congenital muscular torticollis: a case report. Pediatr Phys Ther. 2005 Fall;17(3):209-18. doi: 10.1097/01.pep.0000179176.20035.f0.
- Background: PubMed 11249171Cheng JC, Chen TM, Tang SP, Shum SL, Wong MW, Metreweli C. Snapping during manual stretching in congenital muscular torticollis. Clin Orthop Relat Res. 2001 Mar;(384):237-44. doi: 10.1097/00003086-200103000-00028.
- Background: PubMed 17053679Tscharnuter I. Clinical Application of Dynamic Theory Concepts According to Tscharnuter Akademie for Movement Organization (TAMO) Therapy. Pediatr Phys Ther. 2002 Spring;14(1):29-37.
- Background: PubMed 21145518Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.
- Background: PubMed 21068640Rahlin M, Sarmiento B. Reliability of still photography measuring habitual head deviation from midline in infants with congenital muscular torticollis. Pediatr Phys Ther. 2010 Winter;22(4):399-406. doi: 10.1097/PEP.0b013e3181f9d72d.
- Background: PubMed 17057466Blanchard Y, Neilan E, Busanich J, Garavuso L, Klimas D. Interrater reliability of early intervention providers scoring the alberta infant motor scale. Pediatr Phys Ther. 2004 Spring;16(1):13-8. doi: 10.1097/01.PEP.0000113272.34023.56.
- Background: PubMed 22729134Rahlin M, McCloy C, Henderson R, Long T, Rheault W. Development and content validity of the Therapy Behavior Scale. Infant Behav Dev. 2012 Jun;35(3):452-65. doi: 10.1016/j.infbeh.2012.03.001. Epub 2012 Jun 26.
- Derived from this study: PubMed 38484092Rahlin M, Haney NB, Barnett J. Perception-Action Approach Versus Standard Care for Infants With Congenital Muscular Torticollis: A Pilot Single-Blind Randomized Controlled Trial. Phys Ther. 2024 Apr 2;104(4):pzae038. doi: 10.1093/ptj/pzae038.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Mary Rahlin, PT, DHS, PCS principal investigator
Rosalind Franklin University of Medicine and Science
Nancy Haney, PT, MS principal investigator
Rady Children' Hospital, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Stretching and Perception-Action Approach in people with Congenital Muscular Torticollis, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 12 May 2020. 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 United States. 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 was stopped early (reason given: Study stopped due to COVID-19 pandemic and will not resume.). Results are not available in the source record.
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?
Still Photography (time frame: At baseline and week 5). The study lists 5 primary outcomes in all. 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 NCT02824848, which also lists 9 linked publications.
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 12 May 2020.