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

Primary Purpose

Cerebral Palsy

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Flywheel resistance exercise
Weight-stack resistance exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flywheel resistance exercise

Weight-stack resistance exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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.
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
Gross motor function
Gross motor function will be assessed using Gross Motor Function Measure (GMFM)
Balance
Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital
Muscle spasticity
Spasticity will be assessed using the Ashworth scale

Secondary Outcome Measures

Subcutaneous fat thickness
Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques

Full Information

First Posted
March 17, 2017
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03124628
Brief Title
Effects of Flywheel Exercise on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
Acronym
CP-Flywheel
Official Title
Effects of Flywheel Resistance Exercise Training on Muscle and Walking Function in Teenagers and Young Adults With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 To compare the efficacy of eccentric-overload vs. weight stack resistance exercise in inducing muscle, functional and gait performance adaptations in teenagers with CP. To increase force, power and muscle mass in the lower limbs of patients with cerebral palsy. To improve gross motor function, balance and gait through eccentric-overload resistance exercise in teenagers suffering from cerebral palsy. We hypothesize that the time-effective flywheel resistance exercise paradigm will result in greater gains in muscle mass and function in teenagers with CP, when compared with conventional weight-stack technology. Importantly, we believe these adaptations will be translated into enhanced gross motor function, balance and gait performance. Forty teenagers and young adults (age range 16-23 yr) with spastic CP will be recruited. They will be randomly assigned to flywheel (FL; n=20) or weight-stack (WS; n=20) resistance exercise. During 8 weeks, all the teenagers will follow a standard resistance exercise training program within the Stockholm Habilitation Center system. In addition, patients will perform either flywheel (FL group) or conventional (WS group) leg press resistance exercise twice per week. Muscle force, power and activity (electromyography; EMG), leg extension lag, co-contraction, balance, functional mobility, gait quality, and muscle and fat thickness of lower extremities are assessed in all patients before and after the 8-week intervention (Fig. 1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flywheel resistance exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Weight-stack resistance exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flywheel resistance exercise
Other Intervention Name(s)
Yo-Yo technology
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Weight-stack resistance exercise
Other Intervention Name(s)
Conventional resistance exercise
Intervention Description
Conventional weight-stack resistance exercise
Primary Outcome Measure Information:
Title
Muscle performance
Description
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.
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Muscle architecture
Description
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.
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Electromyography of lower limb muscles
Description
Muscle activation (mV) will be assessed in lower limb muscles (i.e. vastus lateralis, biceps femoris, gluteus medius, medial gastrocnemius) using surface electromyography techniques
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Assessment of activities of daily living
Description
Assessment of activities of daily living is measured using the Timed Up-and-Go test, the Chair-stand and the 6-min walking test.
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Gait performance adaptations to training including muscle activation and co-contraction during walking
Description
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
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Gross motor function
Description
Gross motor function will be assessed using Gross Motor Function Measure (GMFM)
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Balance
Description
Static and dynamic balance is assessed using force platforms at the Motion Analysis Laboratory, Astrid Lindgren Children's Hospital
Time Frame
Change from pre- to post-intervention (8 wks)
Title
Muscle spasticity
Description
Spasticity will be assessed using the Ashworth scale
Time Frame
Change from pre- to post-intervention (8 wks)
Secondary Outcome Measure Information:
Title
Subcutaneous fat thickness
Description
Subcutaneous fat thickness of the thigh of both legs will be assess using ultrasound techniques
Time Frame
Change from pre- to post-intervention (8 wks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria Surgical treatments of the knee extensor apparatus within the last 12 months Botulinum toxin treatment within the last six months Ongoing intrathecal baclofen treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Pontén, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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