Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy

NCT03124628 | Withdrawn DMC

• 2 other identifiers: Flywheel CP16037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this project is to improve physical function and muscle health in teenagers and young adults with cerebral palsy (CP) by using an eccentric-overload resistance exercise model Specific aims

1. 1.To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP.
2. 2.To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy.
3. 3.To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (8)

• Muscle performance

  Unilateral maximal voluntary isometric force is measured in both legs with force sensors. Similarly, unilateral (both legs) concentric and eccentric peak power is assessed through an encoder system. Furthermore, dynamic force during concentric and eccentric actions is measured via force sensors.

  Change from pre- to post-intervention (8 wks)

• Muscle architecture

  Vastus lateralis muscle thickness, together with fascicle pennation angle and muscle echogenicity, will be assessed using ultrasound technique in both legs. Thigh circumference will be assessed using measurement tape.

  Change from pre- to post-intervention (8 wks)

• Electromyography of lower limb muscles

  Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques

  Change from pre- to post-intervention (8 wks)

• Assessment of activities of daily living

  Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.

  Change from pre- to post-intervention (8 wks)

• Gait performance adaptations to training including muscle activation and co-contraction during walking

  Gait performance will be analyzed using an 8-camera 3-D kinematic VICON system and force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital. Overall gait pathology will also be assessed using the multivariate Gait Deviation Index. Muscle activation and co-contraction during gait will be assessed using wireless surface electromyography

  Change from pre- to post-intervention (8 wks)

• Gross motor function

  Gross motor function will be assessed using Gross Motor Function Measure (GMFM)

  Change from pre- to post-intervention (8 wks)

• Balance

  Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital

  Change from pre- to post-intervention (8 wks)

• Muscle spasticity

  Spasticity will be assessed using the Ashworth scale

  Change from pre- to post-intervention (8 wks)

Secondary Outcomes (1)

• Subcutaneous fat thickness

  Change from pre- to post-intervention (8 wks)

Study Arms (2)

Flywheel resistance exercise

EXPERIMENTAL

During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform flywheel leg press resistance exercise twice per week.

Other: Flywheel resistance exercise

Weight-stack resistance exercise

ACTIVE COMPARATOR

During 8 weeks, all the subjects will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients in this arm will perform conventional, weight-stack leg press resistance exercise twice per week.

Other: Weight-stack resistance exercise

Interventions

Flywheel resistance exercise OTHER

Flywheel resistance exercise, originally designed to maintain function, size and quality of skeletal muscle during spaceflight, employs iso-inertial technology rather than gravity dependent weights, which allows for coupled accommodated concentric and eccentric muscle actions, and brief episodes of eccentric overload.

Also known as: Yo-Yo technology

Flywheel resistance exercise

Weight-stack resistance exercise OTHER

Conventional weight-stack resistance exercise

Also known as: Conventional resistance exercise

Weight-stack resistance exercise

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Teenagers and young adults between 16-25 years of age
• Unilateral or bilateral spastic cerebral palsy
• Gross Motor Function Classification System (GMFCS) of level I, II or III.

You may not qualify if:

• Surgical treatments of the knee extensor apparatus within the last 12 months
• Botulinum toxin treatment within the last six months
• Ongoing intrathecal baclofen treatment

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Eva Pontén, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 24, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)