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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Spastic Cerebral Palsy

Treatments: Other: Casting of the lower limb and homebased stretching exercise program.

Study type: Interventional

Funder types: Other

Identifiers

NCT04904094

s59945_B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Casting of the lower limb and homebased stretching exercise program.

Control group

No Intervention group

Description:

This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.