Congenital Muscular TorticollisP-AANCT02907801
Perception-Action Approach Intervention for Infants With Congenital Muscular Torticollis
A study testing 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
Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. 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?
- Perception-Action Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2017to 26 Mar 2018
- 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 CMT as documented in the medical record
- parents/guardians agree not to have their child participate in any additional interventions for CMT during the course of the study
Who cannot join
- diagnosis of neuromuscular torticollis, Sandifer syndrome, acute torticollis, benign paroxysmal torticollis, ocular torticollis, torticollis related to bony anomalies, or another non-muscular type of torticollis
- being seen for torticollis by another health care provider
- receiving a passive stretching intervention for CMT prior to referral for PT at the research site
Trial locations and contacts
1 site in 1 country.
United States1 site
Ability Pediatric Physical Therapy, LLC
Anchorage, Alaska, 99508
About this study
Official title: Effects of Perception-Action Approach Intervention in Infants With Congenital Muscular Torticollis: A Randomized Nonconcurrent Multiple Baseline Study
Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. This study will investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion, and functional use of both sides of the body in infants with CMT.
The participants will be 3 infants with CMT, aged birth to 9 months. A randomized, nonconcurrent A-B multiple baseline design across subjects will be used. The intervention phase will include 5 daily PT sessions, with outcome data collected at the end of each session.
It is hypothesized that improvements on all outcome measures will be documented upon the initiation of the P-A Approach intervention, with the most substantial change expected in habitual head deviation from midline measured by still photography.
Read the detailed description
This study will have a randomized, nonconcurrent A-B multiple baseline design across subjects. The purpose of this study will be to investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion (ROM), and functional use of both sides of the body in infants with CMT.
The participants will be 3 infants with CMT, aged birth to 9 months, recruited from a private pediatric physical therapy (PT) practice. Baseline and intervention data will be collected 5 days per week, Monday through Friday, until the study is completed. The length of the baseline phase will be randomly assigned to each consecutively enrolled participant. The appropriate measurements will be taken at every baseline phase session but no intervention will be provided until the intervention phase is initiated. The intervention phase will include 5 daily PT sessions during which the P-AA intervention will be used, with outcome data collected at the end of each session. Additionally, the participants' therapy-related behavior during intervention sessions will be documented.
Measurements of still photos and scoring of video recordings to evaluate the participants' habitual head deviation from midline and functional use of both sides of the body for movement and play will be performed by an assessor blind to the timing of when the photos and videos are obtained within the study. The active head rotation ROM measurements and assessment of therapy-related behavior will be performed by the treating therapists.
Prior to initiating this research, a pilot reliability study will be conducted for all outcome measures. A total of 3 to 5 infants will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a checklist. During the main study, intervention adherence will be assessed by tracking attendance, session duration, and intervention frequency.
- Conditions
- Congenital Muscular Torticollis
- Being tested
- Perception-Action Approach
- Keywords
- congenital muscular torticollis, infants, 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.
Perception-Action ApproachBehavioural
Also called Perceptual-motor intervention, physical therapy
Environmental set-up, gentle manual guidance, and caregiver education
| Study group | Role | What they receive |
|---|---|---|
| Perception-Action Approach | Experimental | Perception-Action Approach (P-AA) intervention components include environmental set-up for activity and participation in play, manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions, and caregiver education in modifications to everyday activities consistent with the P-AA. All 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 the environmental supports and therapist's hands 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: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
Arthrodial Goniometry
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Measured: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
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: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
Secondary outcomes (1)
Therapy Behavior Scale (TBS), Version 2.2
The TBS score documents therapy-related behavior during intervention sessions
Measured: 5 days (assessed after each of 5 intervention sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start10 Jan 2017
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Why it stopped: After a reliability pilot, main study stopped due to unrelated clinic closure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Ability Pediatric Physical Therapy, LLC
- 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 Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907801
- Sponsor's protocol ID
- 433 PT
- Acronym
- P-AA
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 16357675Tscharnuter 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 17053679Romeiser Logan L, Hickman RR, Harris SR, Heriza CB. Single-subject research design: recommendations for levels of evidence and quality rating. Dev Med Child Neurol. 2008 Feb;50(2):99-103. doi: 10.1111/j.1469-8749.2007.02005.x.
PubMed 18201299Rahlin 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 21068640Rahlin 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 22729134
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perception-Action Approach Intervention in Infants With Congenital Muscular Torticollis: A Randomized Nonconcurrent Multiple Baseline Study
- ClinicalTrials.gov ID
- NCT02907801
- Acronym / sponsor ID
- P-AA / 433 PT
- Conditions
- Congenital Muscular Torticollis
- Keywords
- congenital muscular torticollis, infants, perception-action approach
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After a reliability pilot, main study stopped due to unrelated clinic closure.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Ability Pediatric Physical Therapy, LLC
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 20 Sep 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.
Infants with congenital muscular torticollis (CMT) display postural and functional asymmetry that interferes with their development. The use of the Perception-Action Approach (P-AA) intervention in infants with CMT is supported by a single case report and needs to be researched further to determine its efficacy. This study will investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion, and functional use of both sides of the body in infants with CMT.
The participants will be 3 infants with CMT, aged birth to 9 months. A randomized, nonconcurrent A-B multiple baseline design across subjects will be used. The intervention phase will include 5 daily PT sessions, with outcome data collected at the end of each session.
It is hypothesized that improvements on all outcome measures will be documented upon the initiation of the P-A Approach intervention, with the most substantial change expected in habitual head deviation from midline measured by still photography.
Detailed description
This study will have a randomized, nonconcurrent A-B multiple baseline design across subjects. The purpose of this study will be to investigate the immediate effects of the P-AA intervention on habitual head deviation from midline, active head rotation range of motion (ROM), and functional use of both sides of the body in infants with CMT.
The participants will be 3 infants with CMT, aged birth to 9 months, recruited from a private pediatric physical therapy (PT) practice. Baseline and intervention data will be collected 5 days per week, Monday through Friday, until the study is completed. The length of the baseline phase will be randomly assigned to each consecutively enrolled participant. The appropriate measurements will be taken at every baseline phase session but no intervention will be provided until the intervention phase is initiated. The intervention phase will include 5 daily PT sessions during which the P-AA intervention will be used, with outcome data collected at the end of each session. Additionally, the participants' therapy-related behavior during intervention sessions will be documented.
Measurements of still photos and scoring of video recordings to evaluate the participants' habitual head deviation from midline and functional use of both sides of the body for movement and play will be performed by an assessor blind to the timing of when the photos and videos are obtained within the study. The active head rotation ROM measurements and assessment of therapy-related behavior will be performed by the treating therapists.
Prior to initiating this research, a pilot reliability study will be conducted for all outcome measures. A total of 3 to 5 infants will be recruited for the pilot project.
Fidelity of intervention will be evaluated during the pilot study using a checklist. During the main study, intervention adherence will be assessed by tracking attendance, session duration, and intervention frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perception-Action Approach | Experimental | Behavioral: Perception-Action ApproachPerception-Action Approach (P-AA) intervention components include environmental set-up for activity and participation in play, manual guidance in the form of light pressure applied to the infant's body in developmentally appropriate positions, and caregiver education in modifications to everyday activities consistent with the P-AA. All 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 the environmental supports and therapist's hands 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 CMT as documented in the medical record
- parents/guardians agree not to have their child participate in any additional interventions for CMT during the course of the study
Key exclusion criteria (3 listed)
- diagnosis of neuromuscular torticollis, Sandifer syndrome, acute torticollis, benign paroxysmal torticollis, ocular torticollis, torticollis related to bony anomalies, or another non-muscular type of torticollis
- being seen for torticollis by another health care provider
- receiving a passive stretching intervention for CMT prior to referral for PT at the research site
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 |
|---|---|---|
| Perception-Action ApproachAlso: Perceptual-motor intervention, physical therapyEnvironmental set-up, gentle manual guidance, and caregiver education | Behavioural | Perception-Action Approach |
Primary outcome
Still Photography
Time frame: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
Change in the angle of habitual head deviation from midline assessed in a supine position
Arthrodial Goniometry
Time frame: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
Change in the angular difference in active cervical rotation range of motion between the involved and uninvolved sides
Functional Symmetry Observation Scale (FSOS)
Time frame: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)
Change in the FSOS score that reflects functional use of both sides of the body during spontaneous movement and play
1 secondary outcome
Therapy Behavior Scale (TBS), Version 2.2
Time frame: 5 days (assessed after each of 5 intervention sessions)
Results and safety
The study was stopped early (reason given: After a reliability pilot, main study stopped due to unrelated clinic closure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- 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 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 18201299Romeiser Logan L, Hickman RR, Harris SR, Heriza CB. Single-subject research design: recommendations for levels of evidence and quality rating. Dev Med Child Neurol. 2008 Feb;50(2):99-103. doi: 10.1111/j.1469-8749.2007.02005.x.
- 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 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.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 3 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 13 Aug 2018. 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: After a reliability pilot, main study stopped due to unrelated clinic closure.). 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: Up to 12 days (assessed at every baseline session and at the end of every intervention session for a total of 10, 11 or 12 sessions, depending on the length of the baseline phase)). The study lists 3 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 NCT02907801, which also lists 6 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 13 Aug 2018.