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

The effect of novel Head And Trunk Control Rehabilitation (HATCoRe) device on head and trunk control in children with Cerebral Palsy - HATCoRe

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041269

Enrollment

Registered

2022-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G800- Spastic quadriplegic cerebral palsy

Interventions

Intervention1: 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 l

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Head Control Scale (HCS) 2. Segmental Assessment of trunk Control (SATCO)Timepoint: 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

Measure	Time frame
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 Timepoint: 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.	—

Measure

Time frame

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 Timepoint: 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.

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Countries

India

Contacts

Public ContactDr Sivakumar Gopalakrishnan

Manipal College of Health Professions

bhamini.kr@manipal.edu8660644145

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026