Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06486987
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
CHAMP T 2 Pilot of CIMT by Tele-Video
Sponsor:
Warren Lo
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Efficacy of Constraint Induced Movement Therapy Delivered by Tele-Video for Children With Hemiplegic Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CHAMP-T2 study is a pilot test of the efficacy of constraint induced movement therapy CIMT when delivered by tele-video in the childs home or home-like environment This study will examine the pre- post-intervention function a hemiparetic limb in children who have hemiplegic cerebral palsy The purpose is to provide an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care
Detailed Description:
The CHAMP-T2 study is a pilot study of the efficacy of constraint induced movement therapy CIMT when delivered by tele-video in the childs home or home-like environment This study will examine the pre- post-intervention function of the paretic limb in children who have hemiplegic cerebral palsy The purpose is to develop an effect size estimate that will inform the design of a future study that will compare tele-delivered CIMT with usual and customary care
Primary Aim We will determine the effect of tele-delivered CIMT CHAMP-T protocol upon upper extremity UE motor function in school-aged children with post-stroke hemiparesis We hypothesize that the motor function of the paretic UE will improve significantly following tele-delivered CIMT
The primary outcome will be the change in function of the impaired upper limb as measured by the Melbourne Assessment of Unilateral Upper Limb Function MAUULF 16 The secondary outcome will be the use of the affected limb in bilateral function as assessed with the Assisting Hand Assessment AHA17 a well-established measure of an impaired upper limb in bilateral activities that is validated in children ages 18 months to 18 years We will have the parents report their observation of the function of the affected limb also at baseline and at the end of the 4-week intervention We will use the Pediatric Motor Activity Log PMAL18 which is a published validated measure that we have included in our other studies1 Fidelity to the treatment protocol will be assessed by parents logs of the number of hours of treatment intervention the child undergoes the recorded hours that the child wears the splint and review of the recorded video sessions Parent-therapist communication will be assessed by the Parent-Therapist information exchange tool Factors affecting treatment delivery including obstacles and barriers to task performance as well as supports that might assist performance in a larger clinical trial will be evaluated through semi-structured interviews and observations of treatment sessions with the parent and the treating therapist
We propose a pre- post-intervention assessment of the effect of tele-delivered CIMT delivered for 60 hrs over 4 weeks upon motor function of the paretic UE After informed consent is obtained families will be asked to provide details regarding the childs medical history and diagnoses previous treatments for cerebral palsy and will be assessed for cerebral palsy severity
We will treat 10 children with hemiplegic cerebral palsy with the CHAMP-T2 protocol Five families will be trained in- person by the therapists regarding basic principles of CIMT and how to use the televideo ensemble Five families will receive the same training virtually The CHAMP-T2 version of CIMT will be delivered 3 hours per day 5 days per week for 4 weeks by tele-delivery in the subjects home The therapist will work with the parent by tele-video for 2 of the 3 hours to deliver the CIMT The parent will work directly with the child without the therapist for a 3rd hour of each session The children will wear the immobilization splint continuously each day up to 90 of the waking hours during the CIMT intervention period of 4 weeks
The children will have UE motor function assessment at baseline and immediately post-treatment performed by blinded assessors The parents patients and treating therapists will not be blinded
After enrollment a baseline assessment of motor function will be performed at the study center For five children the therapist then will travel to the childs home for 2 days of in-person training of the parent in the principles of CIMT and in the use of the iPad-Kubi Robot device For the remaining five children the training will be performed by video In the treatment phase of the study the therapist will lead each therapy session by video for the first and third hours of the intervention The second hour the parent will deliver the CHAMP-T2 intervention without the therapist on-line During the therapist participation they will integrate parent coaching in the sessions to increase parent engagement and confidence with their delivery of the intervention Video will be streamed live and recorded Parent training and coaching will incorporate key elements observation action reflection feedback and joint planning 19 along with developing shared goal setting problem solving and provision of feedback education
Primary Aim We will determine the effect of tele-delivered CIMT CHAMP-T protocol upon upper extremity UE motor function in school-aged children with post-stroke hemiparesis We hypothesize that the motor function of the paretic UE will improve significantly following tele-delivered CIMT
The primary outcome will be the change in function of the impaired upper limb as measured by the Melbourne Assessment of Unilateral Upper Limb Function MAUULF 16 The secondary outcome will be the use of the affected limb in bilateral function as assessed with the Assisting Hand Assessment AHA17 a well-established measure of an impaired upper limb in bilateral activities that is validated in children ages 18 months to 18 years We will have the parents report their observation of the function of the affected limb also at baseline and at the end of the 4-week intervention We will use the Pediatric Motor Activity Log PMAL18 which is a published validated measure that we have included in our other studies1 Fidelity to the treatment protocol will be assessed by parents logs of the number of hours of treatment intervention the child undergoes the recorded hours that the child wears the splint and review of the recorded video sessions Parent-therapist communication will be assessed by the Parent-Therapist information exchange tool Factors affecting treatment delivery including obstacles and barriers to task performance as well as supports that might assist performance in a larger clinical trial will be evaluated through semi-structured interviews and observations of treatment sessions with the parent and the treating therapist
We propose a pre- post-intervention assessment of the effect of tele-delivered CIMT delivered for 60 hrs over 4 weeks upon motor function of the paretic UE After informed consent is obtained families will be asked to provide details regarding the childs medical history and diagnoses previous treatments for cerebral palsy and will be assessed for cerebral palsy severity
We will treat 10 children with hemiplegic cerebral palsy with the CHAMP-T2 protocol Five families will be trained in- person by the therapists regarding basic principles of CIMT and how to use the televideo ensemble Five families will receive the same training virtually The CHAMP-T2 version of CIMT will be delivered 3 hours per day 5 days per week for 4 weeks by tele-delivery in the subjects home The therapist will work with the parent by tele-video for 2 of the 3 hours to deliver the CIMT The parent will work directly with the child without the therapist for a 3rd hour of each session The children will wear the immobilization splint continuously each day up to 90 of the waking hours during the CIMT intervention period of 4 weeks
The children will have UE motor function assessment at baseline and immediately post-treatment performed by blinded assessors The parents patients and treating therapists will not be blinded
After enrollment a baseline assessment of motor function will be performed at the study center For five children the therapist then will travel to the childs home for 2 days of in-person training of the parent in the principles of CIMT and in the use of the iPad-Kubi Robot device For the remaining five children the training will be performed by video In the treatment phase of the study the therapist will lead each therapy session by video for the first and third hours of the intervention The second hour the parent will deliver the CHAMP-T2 intervention without the therapist on-line During the therapist participation they will integrate parent coaching in the sessions to increase parent engagement and confidence with their delivery of the intervention Video will be streamed live and recorded Parent training and coaching will incorporate key elements observation action reflection feedback and joint planning 19 along with developing shared goal setting problem solving and provision of feedback education
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None