Improving Stretching Interventions for Children With Cerebral Palsy

NCT02766491 | Unknown

• 1 other identifier: Stretching_CP_V1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cerebral palsy (CP) has a prevalence of 1.5-3 per 1000 live births, making it the most common neurological disorder among children in Europe. One of the most frequently observed problems in CP is hypertonia, i.e. increased muscle tension, which can result in contractures. Stretching therapies are widely used as a treatment for contractures, but with highly variable success. Therefore, efforts are needed to improve the efficacy of stretching interventions. The investigators hypothesise that increasing the stiffness of the tendon relative to the muscle, by resistance training, prior to stretching will improve the efficacy of stretching interventions in children with CP. In a RCT design the investigators will compare a group of children receiving a combined strengthening-stretching intervention of the calf muscle to a control group receiving conventional stretching exercises in combination with upper limb exercises. Outcome measures will include muscle-tendon structure and gait analysis to assess functional improvements. This research will improve the understanding of muscle responses to stretching interventions in children with CP and can lead to more effective stretching therapies.

Conditions

Cerebral Palsy

Keywords

Stretching

Outcome Measures

Primary Outcomes (2)

• Change Muscle fascicle length of the Gastrocnemius (mm)

  B-mode ultrasound images will be captured at the mid muscle belly. From these, fascicle length will be defined as the straight line distance between the upper and the lower aponeurosis parallel to the lines of collagenous tissue.

  at baseline and after 10 weeks

• Change in Gastrocnemius muscle length (mm)

  B-mode ultrasound images will be captured of the myotendinous junction and the medial femoral condyl. Muscle length will be defined as the straight line distance between these two anatomical points.

  at baseline and after 10 weeks

Secondary Outcomes (6)

• Change in ankle range of motion (degree)

  at baseline and after 10 weeks

• Change in Achilles tendon stiffness (Nm)

  at baseline, after 4 weeks and after 10 weeks

• Change in maximal dorsiflexion angle during gait (degree)

  at baseline and after 10 weeks

• Change in lengthening properties of the muscle fascicles (mm)

  at baseline and after 10 weeks

• Changes in step length during gait (m)

  at baseline and after 10 weeks

Study Arms (2)

Strengthening and stretching

EXPERIMENTAL

The intervention group will follow a strengthening-stretching program of the calf muscles.

Other: Strengthening and stretching

conventional stretching

ACTIVE COMPARATOR

The control group will receive conventional stretching and strengthening exercises to the upper limb to assure that the same systemic physiological stimuli and a similar number of contact hours is received.

Other: conventional stretching

Interventions

Strengthening and stretching OTHER

Strengthening exercises will be performed 4 times a week for 10 weeks. Single leg heel raises will be the preferred exercise performed. The group of participants will have a wide range of strength and functional abilities, this will be accounted for with individualised programmes. The exercise load can be reduced by switching to bilateral heel raises, giving external support, reducing the range of motion or performing the heel raises while seated. Exercise load will be progressively increased by adding weight in the form of water bottles to a rucksack worn on the participant's back. For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed.

Strengthening and stretching

conventional stretching OTHER

This group will perform seated biceps curls 4 times a week for 10 weeks, where extra load can be added progressively by holding water bottles in the hand. For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed.

conventional stretching

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with spastic cerebral palsy
• GMFCS level I-III
• Have the ability to perform at least one bi-lateral heel raise.
• Aged 7 to 14

You may not qualify if:

• Orthopaedic or neural surgery to the lower limb 2 years prior to or planned during the intervention
• Botulinum Toxin A injections 6 months prior to or planned during the intervention.
• A learning or behaviour impairment that prevents full participation in the intervention.

Sponsors & Collaborators

• Liverpool John Moores University: lead

Related Publications (1)

• Kalkman BM, Holmes G, Bar-On L, Maganaris CN, Barton GJ, Bass A, Wright DM, Walton R, O'Brien TD. Resistance Training Combined With Stretching Increases Tendon Stiffness and Is More Effective Than Stretching Alone in Children With Cerebral Palsy: A Randomized Controlled Trial. Front Pediatr. 2019 Aug 13;7:333. doi: 10.3389/fped.2019.00333. eCollection 2019.

  PMID: 31456995 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas D O'Brien, PhD

  Liverpool John Moores University

  STUDY DIRECTOR

Central Study Contacts

Barbara M Kalkman, Msc

CONTACT

07596722045; B.M.Kalkman@2014.ljmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 9, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share