Neuromusculoskeletal Modeling of Muscle Spasticity

NCT05447299 | Enrolling By Invitation

• 1 other identifier: K 0000-0001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP) is a movement and posture disorder caused by an injury to the developing brain, with a prevalence in Sweden of about 2/1000 live births. Children with CP have walking difficulties, and decreased muscle mass and muscle function as compared to typically developing (TD) children. The extent of disability in CP depends on the severity and timing of the primary cerebral lesion and can be classified with the gross motor function classification system (GMFCS E\&R) that ranges from walking without limitations (I) to being transported in a wheelchair (V). Muscle function commonly deteriorates with age and contracture development is often clinically evident as early as at 4 years of age. In addition to being thinner and weaker, skeletal muscle in children with CP develop poor quality, i.e., increasingly higher amounts of fat and connective tissue at the expense of functional, contractile proteins. How long-term standard treatments for children with spastic CP including, training and orthotics use, with botulinum toxin (BoNT-A) treatment as an adjunct, affects muscle on functional, structural, and microscopic level in CP has not yet been published. Therefore, we will investigate the muscle function as well as functional mobility, structure, and spasticity. We will conduct functional mobility tests. Muscle strength will be measured with a rig-fixed dynamometer, and muscle structure will be measured with magnetic resonance imaging. The spasticity will be instrumentally assessed by the NeuroflexorTM, a machine measuring resistance in a muscle when a pedal is passively moving the participants foot at two different speeds. We will follow participants, for 1 year, with 4 measurements during this period. In order to better treat these children, we need to better understand the complex, interrelated interactions of musculoskeletal properties and function in children with CP. Our hypothesis is that muscle structure and function is affected by standard clinical treatments sessions including routine botulinum toxin treatment. Analyzing the effect of standard care may help planning of more effective clinical treatments in the future.

Conditions

Cerebral Palsy; Musculoskeletal Deformity; Spasticity; Muscle Strength; Walking, Difficulty

Keywords

Spastic cerebral palsy; Muscle function; Hyper-resistance; Functional mobility

Outcome Measures

Primary Outcomes (4)

• Change in muscle structure

  MRI based examinations including muscle volume

  Before and one year after the first treatment session

• Change in spasticity

  Resistance at slow and fast passive movements of the foot

  Before, three months, six months and 12 months after the firstt treatment session

• Change in muscle strength

  Muscle strength measured as force with a dynamomter in the calf muscle

  Before, three months, six months and 12 months after the first treatment session

• Change in functional mobility during walking

  Time to complete a test of functional mobility during walking will be measured

  Before, three months, six months and 12 months after the first treatment session

Study Arms (2)

Typically developing children

Reference group of typically developing children

Cerebral palsy group

Children with a diagnosis of cerebral palsy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with spastic CP are recruited from the Dept of Pediatric Orthopaedics, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden. The TD children are recruited from siblings of the participants with CP, and friends and family of the research group.

You may qualify if:

• Unilateral/Bilateral spastic CP without Botulinum toxin injection history
• Understanding study protocol and expressing voluntary consent of the family
• Dorsiflexion to at least a neutral position of the foot

You may not qualify if:

• Contraindication to MRI scanning: metal fragments in the body, surgically implanted devices containing metal, severe claustrophobia, or inability to lie down in the MRI scanner, presence of pacemaker or other stimulators, shunts etc.
• Total range of ankle movement less than 35°

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska University Hospital: collaborator
• KTH Royal Institute of Technology: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Region Stockholm, Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• Ahblom A, Ponten E, Destro A, Petersson S, von Walden F, Wang R, Lidbeck C. Exploration of the triceps surae muscle in ambulatory children with cerebral palsy using instrumented measurements of stiffness and diffusion tensor magnetic resonance imaging for muscle architecture. BMC Musculoskelet Disord. 2024 Oct 11;25(1):803. doi: 10.1186/s12891-024-07890-4.

  PMID: 39394126 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Mobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• R Wang, Ing, PhD

  KTH Royal Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 7, 2022
• Study Start: January 15, 2019
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 7, 2022

Record last verified: 2022-04

Locations

SE (1)