Use of technology to improve head and trunk control in Cerebral Palsy children

Phase 2

Recruiting

Conditions: Spastic quadriplegic cerebral palsy,

Registration Number: CTRI/2022/03/041269

Lead Sponsor: Shristi Shakya

Brief Summary: 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 childâ€™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 tabletâ€™s HATCoRe application (android app) via Bluetooth module. The childâ€™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 motherâ€™s lap (represented by letter A)

2-4 weeks: A + Intervene in inclined to 45Â° (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 motherâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 6

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Head Control Scale (HCS)	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
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 Measures

Name	Time	Method
3. Bayleys Scale of Infant and Toddlers Development - III(BSID - III)	4. Global Perceived Effect (GPE) Scale

Trial Locations

Locations (1): Manipal College of Health Professions (MCHP), Manipal
🇮🇳
Udupi, KARNATAKA, India
Manipal College of Health Professions (MCHP), Manipal
🇮🇳Udupi, KARNATAKA, India
Shristi Shakya
Principal investigator
8197175393
shakya.shristi94@gmail.com