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Effectiveness of hand-arm bimanual intensive therapy including lower extremities (habit-ile) and home-based habit-ile among children with bilateral cerebral palsy

Effectiveness of hand-arm bimanual intensive therapy including lower extremities (habit-ile) and home-based habit-ile among children with bilateral cerebral palsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001136594
Enrollment
13
Registered
2024-09-20
Start date
2023-07-11
Completion date
2026-02-23
Last updated
2024-09-30

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

Conditions

None listed

Brief summary

Therapist-directed Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in camp effectively improves both upper- and lower extremities function of children with bilateral cerebral palsy (CP). Home-based programs are a vital addition to intensive therapy offered by therapists in hospital or rehabilitation centres. The setting of home-based HABIT-ILE in children with bilateral CP has not been developed and its effectiveness is still unknown. This study aims determine the effectiveness of HABIT-ILE with home-based HABIT-ILE in improving upper and lower extremities function for children with bilateral CP. Besides, parental stress and children’s quality of life, occupational performance, and satisfaction will also be determined.

Interventions

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is based on motor learning and neuroplasticity principles. In addition to addressing the upper extremities, HABIT-ILE also incorporates the trunk and lower extremities, emphasizing the simultaneous control of both upper and lower extremities. Dose: Children in the intervention group will receive in total 55 hours of HABIT-ILE from the therapists in camp with 10 hours of home-based HABIT-ILE in 10 consecutive days. Mode

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is based on motor learning and neuroplasticity principles. In addition to addressing the upper extremities, HABIT-ILE also incorporates the trunk and lower extremities, emphasizing the simultaneous control of both upper and lower extremities. Dose: Children in the intervention group will receive in total 55 hours of HABIT-ILE from the therapists in camp with 10 hours of home-based HABIT-ILE in 10 consecutive days. Mode: Groups of 13 children delivered (2:1 therapist to child ratio). Content and tailoring: For children in group A, they will have HABIT-ILE training in camp for 5.5 hours a day for ten consecutive days, a total of 55 hours. After the daily 5.5 HABIT-ILE training in camp, go home for 1-hour home-based HABIT-ILE training with the therapist remotely guiding the caregiver. Participants in group A will not continue to receive the rehabilitation they originally received in the hospital. Therapists should fill the HABITILE daily log and fill Home-based HABIT-ILE daily log after communicating with Caregivers After the intervention, the children will be reassessed again. A child's abilities and developed functional goals are taken into consideration when selecting activities and tasks to carry out during the intervention. HABIT-ILE involves structured bimanual activities, such as games or functional tasks, requiring systematically the use of both hands, while also involving postural and lower extremity demands. During camp, both upper and lower extremity motor difficulty is gradually increased in complexity as children master the skills. Intervention Providers: Interventions are provided by physical therapists and occupational therapists under the guidance of the HABIT-ILE developers. Target intensity: During the intervention, the routine is organized as follows. From 8:00 in the morning, the supervisor will lead the therapist in confirming the list of activities and making preparations. Ensure that the toys needed are well prepared and have been checked. There will be an intervention starting at 9 o'clock until 2.30 p.m., lasting for 5.5 hours, including a lunch activity at noon. Afterward, the therapist communicates with the caregivers for 30-50 minutes and teaches them what games and activities their child is most interested in during the day. This is so that they can have 1 hour of HABIT-ILE at home under remote video supervision once they return home. Fidelity: HABIT-ILE's original expert team and researcher of this project will supervise therapists throughout the process. Prior to research, supervisors and researcher will train therapists on the principles of motor skill learning, as the principles used for HABITILE. First, a total of eight-hour lectures and a well-prepared handbook designed by supervisors and researchers will be given to recruited therapists. Second, the day before HABIT-ILE and home-based HABIT-ILE, supervisors and researcher will conduct a group meeting with the therapists. Therapists will be supervised in designing interventions and choosing appropriate activities for children. Additionally, supervisors and researcher will guide the grading strategy from accessible to difficult. The interaction between the therapists and the children will be observed during the intervention. Therapists will be provided guidance to make timely adjustments when necessary. There will be assistance from supervisors and researcherin resolving the problems raised. A therapist will guide the caregiver through a home-based HABIT-ILE session through online meeting platform and observe the child's performance to ensure the training plan is adjusted accordingly. After the day's treatment, a discussion time of about an hour is arranged. The therapist needs to report on the child's situation today and discuss with supervisors and researcher to formulate an updated intervention plan for the next day. Games and activities children may receive: HABIT-ILE involves structured bimanual activities, such as games or functional tasks,requiring systematically the use of both hands, while also involving postural and lower extremity demands. During camp, both upper and lower extremity motor difficulty is gradually increased in complexity as children master the skills. As an example, the activities to determine the evolution of the more affected hand in bimanual activities may begin with it acting as a passive support (such as stabilizing paper with weight to make crafts), progressing toward more complex activities (such as grasping or holding a Lego block). A similar progression is made for postural and lower extremity challenges, starting with more stable positions (e.g., sitting on a bench while playing at a table), then progressing to more demanding situations considering balance (e.g., sitting on a fitness ball) or dynamic postures (e.g., standing, walking, or running when possible). The activities always involve the upper and lower extremities, along with postural control. Either the upper or lower extremities increase in difficulty, but not both simultaneously. Sampling method: Recruitment of subjects is conducted using the convenience sample method. Participants were assigned to the intervention or control group in the order in which they entered the study (the first 13 participants will be assigned to the intervention group, and the last 13 participants were assigned to the control group).

Sponsors

Qu Ya-lan - Universiti Kebangsaan Malaysia
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
5 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria for child’s participants: i. age 5 - 12 years old; ii. diagnosed as bilateral CP with Gross motor functional classification (GMFCS) from levels II to IV; iii. could grasp light objects and lift the more affected arm 15cm above a table surface;29 iv. could understand the game and test instructions. Inclusion criteria for caregiver’s participants: i. able to provide one-on-one 1-hour training to the child per day; ii. have a computer or iPad with a camera; iii. had high school education level; iv. age 59 years or younger.

Exclusion criteria

Exclusion criteria for child’s participants: i. has uncontrolled seizures; ii. received botulinum neurotoxin injections or orthopaedic surgery in the previous six months or during the study period; iii. visual problems interfering with treatment; iv. inability to walk even with a walker.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026