| CTRI Number |
CTRI/2022/03/041269 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of technology to improve head and trunk control in Cerebral Palsy children |
|
Scientific Title of Study
|
The effect of novel Head And Trunk Control Rehabilitation (HATCoRe) device on head and trunk control in children with Cerebral Palsy |
| Trial Acronym |
HATCoRe |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shristi Shakya |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Physiotherapy. Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
New International Hostel A Block
Udupi
KARNATAKA
576104
India |
| Phone |
8197175393 |
| Fax |
|
| Email |
shakya.shristi94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy. Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8660644145 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivakumar Gopalakrishnan |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Kasturba Medical College (KMC), Manipal Academy of Higher Education (MAHE), Manipal |
| Address |
Department of Physiology, Kasturba Medical College (KMC), Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844171014 |
| Fax |
|
| Email |
sivakumar.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD, Kasturba Hospital, Manipal, India |
|
|
Primary Sponsor
|
| Name |
Shristi Shakya |
| Address |
Department of Physiotherapy, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shristi Shakya |
Manipal College of Health Professions (MCHP), Manipal |
Department of Physiotherapy, Kasturba Hospital, Room no. 103, Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA |
8197175393
shakya.shristi94@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Physiotherapy HATCoRe device trial |
HATCoRe device is a Bluetooth enabled sensor device, which is attached to a childs cap. It gives us the parameters such as "sustenance time of head lift by the child" and "degree of cervical movement". The device is then connected to an android application via Bluetooth module to connect to a display screen (tablet) to train the head movement in four different position i.e., sitting, inclined, prone and supine, by incorporating "Single Subject Multiple Baseline" design. According to the design, it has baseline, intervention, and follow-up phases.
In the baseline phase (lasting for 4, 6, or 8 weeks), no intervention will be provided to the participants. The outcome measures will be assessed weekly once. At 3rd-week GPE scale will be assessed from the parents. In the intervention phase, three sessions will be conducted weekly for the period of 16 weeks, with the total duration of the intervention 30-45 minutes, approximately. The outcome measures will be assessed fortnightly. At mid-intervention phase, GPE scale will be assessed form the parents. Again, in the follow-up phase of 9 weeks, no intervention will be provided. The outcome measures will be assessed once in 3 weeks for 9 weeks.
All the outcome measures will be evaluated by a blinded investigator. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
i. Children with delayed head control above 2 years of age
ii. Inability to hold the head upright against gravity for less than 1-minute and requiring adaptive seating to support posture adequately
iii. Children with functional vision & hearing
iv. Grade of 0 or 1 in any of 2 of the 4 positions in the Head Control Scale (HCS)
v. Gross Motor Function Classification System (GMFCS) level IV
|
|
| ExclusionCriteria |
| Details |
i. Children with delayed head control above 2 years of age
ii. Inability to hold the head upright against gravity for less than 1-minute and requiring adaptive seating to support posture adequately
iii. Children with functional vision & hearing
iv. Grade of 0 or 1 in any of 2 of the 4 positions in the Head Control Scale (HCS)
v. GMFCS level IV
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Head Control Scale (HCS)
2. Segmental Assessment of trunk Control (SATCO) |
For the baseline phase (4-, 6- or 8-weeks): weekly once
For the intervention phase of 16 weeks: fortnightly
For the follow-up phase of 9 weeks: once in every 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. Bayleys Scale of Infant and Toddlers Development - III(BSID - III)
4. Global Perceived Effect (GPE) Scale
5. Parameters obtained from the device:
i. Sustenance time of head lift
ii. Degree of cervical movement
6. Parameters obtained from the video
i. Number of attempts to lift the head
ii. Successful attempts of head lifts
iii. Total duration of cap worn by the participants
|
For baseline phase, weekly once. GPE scale will be assessed at week-3.
For the intervention phase, outcomes will be assessed fortnightly. GPE scale will be assessed at Day 63 of the intervention phase.
For the follow-up phase of 9 weeks: once in every 3rd week. GPE scale will be assessed after the follow-up phase.
However, BSID - III will be calculated pre i.e. after recruiting participants, after the intervention phase, and post-follow-up phase.
|
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="7" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/11/2022 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Participants will be enrolled according to their eligibility criteria. A participant information sheet will be provided and written informed consent will be obtained. Participants will be screened for their functional vision and hearing. We will be recruiting 6 children with Cerebral Palsy (CP) having delayed or poor head and trunk control ability, with Gross Motor Function Classification System (GMFCS) level IV and V, aged between 2 years and 10 years old. To investigate the effect of novel Head and Trunk Control Rehabilitation (HATCoRe) device on head and trunk control in children with CP, a Single Subject Multiple Baseline Design across participants will be utilized. This study design has a baseline phase, an intervention phase, and a follow-up phase. For our study, a blocked randomization process will be used for the purpose of randomizing the participants into 3 blocks of 2 via with pseudorandom number generator to randomize the participants into 4-, 6- or 8- weeks baseline phases. The outcome measures in the baseline phase will be assessed weekly once. An experienced pediatric physiotherapist will be employed as a blinded investigator to rate the outcome measures, along with the provision of a guide to evaluate the video, to obtain the outcome measures from the parameters obtained from the video. The intervention phase will last for 30-45 minutes per session, two to four times per week, for a period of 12 to 16 weeks, to reduce the potential drop-out of the participants; and the outcome measures will be assessed fortnightly. For the intervention with the HATCoRe device, familiarization time will be provided to the child with the device attached to the child’s cap. The display screen (tablet) will be placed at a distance of 100 cm in front of the participants. The device is connected to the tablet’s HATCoRe application (android app) via Bluetooth module. The child’s profile is set in the device, and his/her desired auditory and visual stimulus is selected in the profile. The HATCoRe device will be calibrated for sagittal (flexion-extension), transverse (rotations), coronal planes (lateral flexions), and diagonal movements for the desired head movements for the session, and the training is begun in sitting, inlined, supine, and prone positions for all the planes of cervical movements. The session is then begun. Progression of intervention: 0-2 weeks: Participant will be intervened on mother’s lap (represented by letter A) 2-4 weeks: A + Intervene in inclined to 45° (represented by letter B) 4-6 weeks: A + B + Intervened in supine (represented by letter C) 6-8 weeks: A + B + C + Intervened in prone (represented by letter D) 8-16 weeks: A + B + C + D An auditory stimulus is provided to initiate the target (head and trunk) movements. The position of the child will be on the mother’s lap for 0-2 weeks. As the child lifts the head to look around for the auditory stimulus, an image or animation will be shown on the display screen which is placed centrally in the tablet, if the child keeps his head upright. Another auditory stimulus is provided if the child is unable to sustain the head position, to encourage the child to maintain the optimal head position for a longer duration. If the child is able to retain the optimal (head and trunk aligned) position, a reward auditory stimulus will be provided to the child. Similarly, the intervention is progressed in the order mentioned above. Similarly, for 2 to 4 weeks, the intervention will be carried out in inclined to prone position, for the next 4 to 6 weeks, in the prone position, for the next 6 to 8 weeks, in the supine position, and the same 4 positions will be conducted in the next 8 to 16 weeks of interventions. The follow-up phase will last for a period of 9 weeks, wherein the outcome measures will be assessed once every third week. The outcome measures are the Head Control Scale (HCS), Segmentl Assessment of Trunk Control (SATCo)< Gross Motor Function Measure-66 (GMFM-66), Global Perceived Effect Scale (GPE), and the parameters obtained from the device such as "Number of attempts to lift the head, sustenance time of head lift, successful attempts of head lift, degree of cervical range of motion, and the total duration of time the child had worn the HATCoRe device. The primary outcome measures are HCS and SATCo. All the outcome measures will be assessed weekly once in the baseline phase, fortnightly in the intervention phase and once in 3 weeks in the follow-up phase, except for the GPE and GMFM-66 which will be recorded immediately after the recruitment, after the intervention phase and after the follow-up phase. A structured and systematic visual analysis (level, trend, variability, immediacy of effect, and Percentage of Non-Overlapping Data (PND) supplemented with statistical analyses (celeration line) will be used to analyze the data.
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