Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

Study Overview
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Brief Summary
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This study will investigate the effect of a 6-week stretching intervention, consisting of a combination of a 2-week casting period and a home-based stretching program of the plantar flexors and hamstrings, on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The study will include patients with spastic cerebral palsy aged between 4 and 11 years old with a Gross Motor Function Classification Score (GMFCS) level between I and III.

Detailed Description
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This study will investigate the effect of a 6-week stretching intervention on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The program consists of a 2-week casting period of the lower legs and a home-based stretching program of the hamstrings, followed by a 4-week stretching program of both the plantar flexors and hamstrings. The aim is twofold: (1) determine whether a 6-week stretching program for the plantar flexors and knee flexors leads to changes in the morphological muscle and tendon properties of the medial gastrocnemius and semitendinosus, ankle and knee range of motion, muscle strength, gait and gross motor function; and (2) determine the correlation between baseline morphological muscle and tendon properties and the changes in the primary outcome parameters (ankle range of motion and stiffness). The program will start with a 2-week period of stretching casts for the ankle plantar flexors, combined with a passive stretch program for the hamstrings, followed by a passive and active stretch program for both muscle groups for the remaining 4 weeks. The durations and frequencies for passive and active stretching are based on guidelines published by our own research group and on programs applied by previous research. The program will be set-up as a supervised home-based program on top of the usual care. The morphological muscle and tendon parameters, strength, spasticity, stiffness as well as gross motor function will be assessed before and after the entire 6-week stretching program. At the time of cast removal (after 2 weeks), only the morphological muscle and tendon parameters will be evaluated. This study includes an intervention and control group which will be group-matched based on diagnosis, GMFCS level and age. The study will include patients with spastic cerebral palsy between 4 and 11 years old and a GMFCS level between I and III. Thirty children with a clinical indication for casting of the lower limb will be included in the intervention group and 30 children without an indication for a specific intervention will be included in the control group. Children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.

Official Title
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Algorithms for Patient-specific Treatment Planning in Cerebral Palsy Based on the Muscle and Tendon Architecture - Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

Conditions
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Spastic Cerebral Palsy

Intervention / Treatment
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* Other: Casting of the lower limb and homebased stretching exercise program.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of spastic cerebral palsy Aged 4-12 years GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment) Sufficient cooperation to comprehend and complete the test procedure Indication for casting of the lower limb Exclusion Criteria: Non-ambulatory Botulinum toxin A injections six months prior to enrollment Lower limb surgery two years prior to enrollment Selective dorsal rhizotomy as treatment history Presence of ataxia or dystonia Cognitive problems that impede measurements Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will include patients who receive casting at the lower limb for the intervention group. Patient with no indication for treatment will be asked for participation in the control group. The children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This group will receive casting of the lower limb for approximately 2 weeks combined with a passive stretching program of the knee flexors, followed by a homebased stretching exercise program for the plantar flexors and hamstrings for 4 weeks after casting. | Other: Casting of the lower limb and homebased stretching exercise program.<br>* Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.<br>|
| No Intervention: Control group<br>This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle belly and tendon length of the medial gastrocnemius and semitendinosus | Estimation of the muscle belly and tendon length by 3D freehand ultrasonography. The primary outcome will be the muscle belly/tendon length ratio. | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 
| Change of range of motion of the ankle and knee joint | Evaluation by an instrumented spasticity assessment | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 
| Change of range of motion of the ankle and knee joint | Evaluation by goniometry | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle neural (spasticity) and non-neural (stiffness) hyper-resistance | Evaluation of muscle spasticity and stiffness by an instrumented spasticity assessment | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 
| Change in functional muscle strength | Evaluation of functional muscle strength by the Adapted Functional Strength measure | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 
| Change in muscle echointensity | Estimation of the echointensity by 3D freehand ultrasonography | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 
| Change in muscle volume | Estimation of muscle volume by 3D freehand ultrasonography | Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, spastic cerebral palsy, stretching intervention, muscle morphology, range of motion, stiffness, spasticity