Robotic TruST-Postural Intervention for Children With Cerebral Palsy
NCT ID: NCT04897347
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2022-02-26
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Robotic Trunk-Support-Trainer (TruST)
Postural-reaching control intervention with TruST
Robotic Trunk-Support-Trainer (TruST)
This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.
\- Twelve 2hr training sessions (3 times per week for 4 weeks)
Static Trunk Support
Postural-reaching control intervention with Rigid Trunk Support
Static Trunk Support
This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.
\- Twelve 2hr training sessions (3 times per week for 4 weeks)
Interventions
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Robotic Trunk-Support-Trainer (TruST)
This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.
\- Twelve 2hr training sessions (3 times per week for 4 weeks)
Static Trunk Support
This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.
\- Twelve 2hr training sessions (3 times per week for 4 weeks)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
* Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV
* Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
* Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")
Exclusion Criteria
* Current medical illness unrelated to CP at the time of the study
* Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
* History of recurrent seizures (daily) or drug-resistance epilepsy
* Severe Spinal Deformities: scoliosis \>40◦ and/or kyphosis \>45◦
* Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months
* Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4)
* Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study
* Other major surgeries in the previous 6 months (if medically contraindicated)
6 Years
17 Years
ALL
No
Sponsors
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Columbia University
OTHER
Teachers College, Columbia University
OTHER
Responsible Party
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Principal Investigators
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Sunil Agrawal, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Andrew Gordon, PhD
Role: PRINCIPAL_INVESTIGATOR
Teachers College, Columbia University
Locations
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Columbia University
New York, New York, United States
Teachers College, Columbia University
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Victor Santamaria, PT, PhD
Role: primary
Karen Chin, MA
Role: primary
References
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Santamaria V, Ai X, Chin K, Dutkowsky JP, Gordon AM, Agrawal SK. Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems. BMJ Open. 2023 Aug 17;13(8):e073166. doi: 10.1136/bmjopen-2023-073166.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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AAAS7804
Identifier Type: -
Identifier Source: org_study_id