Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy

This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy; Bilateral Cerebral Palsy
• Intervention / Treatment: Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities; Behavioral: Conventional intervention

Detailed Description

This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yannick Bleyenheuft, Professor; Phone Number: +3227649349; Email: yannick.bleyenheuft@uclouvain.be
• Study Contact Backup: Name: Elisa Vancolen, PhD student; Phone Number: +32473256219; Email: elisa.vancolen@uclouvain.be

Study Locations

• Belgium
  • Brabant-Wallon
    • Louvain-La-Neuve, Brabant-Wallon, Belgium, 1348
      • Faculté des Sciences de la Motricité (UCLouvain)
      • Contact: Yannick Bleyenheuft, Professor; Phone Number: +32 2 764 93 49; Email: yannick.bleyenheuft@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosed bilateral cerebral palsy,
• Adults aged 18 to 50 years old,
• Level of manual ability : level I to V of MACS
• Level of gross motor function : level I to IV of GMFCS
• Ability to follow instructions and complete testing,
• Ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted).

Exclusion Criteria:

• Unstable seizure
• Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
• Alcohol/drug abuse
• Pregnancy
• Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
• Uncontrolled health issues (cardiac, metabolic...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HABIT-ILE	Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities; The HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each participant will be supported by one or two therapists and supervised by a trained team to ensure the program is delivered effectively and safely. The therapy emphasizes engaging, play-based activities to maximize motivation and active participation.
Active Comparator: Conventional intervention	Behavioral: Conventional intervention; Participants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gross Motor Function Measurement (GMFM-66)	Measurement of change in gross motor function over time in adults with cerebral palsy.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle strength (Biodex System 4 pro®)	Measurement of maximal isometric muscle strength for specific lower limb and upper limb muscles using a Biodex System 4 pro® (Biodex Medical Systems, Inc., Shirley, NY, USA) isokinetic device.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle strength (Jamar)	Measurement of grip strength using the Jamar dynamometer.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle range of motion (Biodex System 4 pro®)	Assessment of passive and active range of motion for targeted joints using the Biodex System 4 Pro® dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuromuscular command (muscle co-contraction)	Evaluation of muscles co-contraction in lower limbs and upper limbs by combining isometric force measurements with electromyography (EMG) recordings to monitor the activation patterns of agonist and antagonist muscles during contractions.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in unimanual dexterity (Box and Blocks Test - BBT)	Measurement of gross manual dexterity by counting how many blocks a participant can transfer from one side of a box to the other in one minute	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in the 2-Minutes' Walk Test (2MWT)	Measurement of the maximum distance covered by the patient in a 2-minutes' walk test, assessing the endurance and walking ability over a short duration.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in spinal function (electromyography - EMG)	Evaluation of spinal function through electromyography (EMG) during the 2-minutes' walk test, assessing muscle activation and coordination of the spinal cord during walking	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain perception (Quantitative Sensory Testing - QST)	Measurement of sensory response to determine pain threshold and pain perception.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily pain perception (Ecological Moment Assessment)	Ecological assessment of daily pain perception using a smartphone application sending randomized notifications throughout the day to prompt the patient to report their pain levels.	Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up
Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF)	Questionnaire assessing the severity of pain and its impact on functioning.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuropathic pain (PROMIS PQ-Neuro)	Questionnaire designed to identify patients likely experiencing neuropathic pain and to assess its severity.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in perception of pain (Pain Catastrophizing Scale - PCS)	Questionnaire assessing the extent of catastrophic thinking related to pain, including rumination, magnification, and helplessness, across three subscales. The total score ranges from 0 to 52 (higher scores indicate a greater degree of pain catastrophizing).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)	Questionnaire assessing five cognitive coping strategies for managing pain-distraction (attention diversion), catastrophising, praying and hoping, ignoring pain sensations, and reinterpreting pain sensations-based on the frequency of use for each strategy.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (General Self-Efficacy Scale - GSES)	Questionnaire assessing the belief in one's ability to handle various difficult situations. Scores range from 10 to 40 (lower scores suggest reduced self-efficacy).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (Canadian Occupational Performance Measure - COPM)	The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10, a higher score means a better performance.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILHAND Questionnaire)	Questionnaire assessing the patient's performance in unimanual and bimanual upper limb activities, with scores ranging from -6 to +6 logits (higher score indicates better performance).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ACTIVLIM-CP Questionnaire)	Questionnaire assessing the patient's ability to perform daily activities using the upper and/or lower limbs, with scores ranging from -5 to +5 logits (higher scores indicates better performance).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILOCO questionnaire)	Questionnaire assessing the patient's ability to perform daily activities using the lower limbs, with scores ranging from -4 to +4 logits (higher scores indicates better performance)	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in participation (Participation in Life Situation Questionnaire - PILS)	Questionnaire assessing the participation and engagement in life situation, assessing how cerebral palsy affects the patient's ability to participate in various activities and social situations.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)	Questionnaire assessing the patient's level of anxiety and depression, with scores ranging from 0 to 21 for both subscales (higher scores indicate higher levels of anxiety of depression).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)	Questionnaire assessing the impact of pain on sleep quality. Scores range from 0 to 30 (higher scores indicate greater disruption to sleep due to pain).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in fatigue (Multidimensional Fatigue Inventory - MFI)	Questionnaire assessing fatigue across five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each subscale score ranges from 4 to 20 (higher scores indicate more severe fatigue in the respective domain).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in quality of life (WHOQOL-BREF)	Questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Scores for each domain range from 4 to 20 (higher scores indicate better quality of life).	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)	Questionnaire assessing perceived cognitive function, focusing on areas such as memory, attention, and problem-solving. It is a 4-item questionnaire, each item uses a 5-point Likert scale ranging from 1 ("Never") to 5 ("Always"), with higher scores indicating worse cognitive functioning.	pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: Paris 12 Val de Marne University

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pain; quality of life; cerebral palsy; adults; motor skill learning; muscle structure; body function; body structure; intensive therapy; activities
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: B403201316810i

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No