Back to resultsFunctional Exercise Training With Adolescents With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
functional exercise training
standard therapy / treatment
Sponsored by
About this trial
This is an interventional other trial for Cerebral Palsy focused on measuring adolescents with cerebral palsy, functional exercise intervention, motor capability, motor capacity, gross motor function measure (GMFM-66)
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of CP.
- Adolescents between 12 and 18 years of age.
- Gross Motor Functional Classification System (GMFCS): I-III.
- Cognitive abilities must include: Ability to actively engage in a training session of 60 min. duration; Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend training, testing and follow-up sessions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.
Exclusion Criteria:
- Any surgery or botulinum toxin treatment within 6 months prior to the start of the study or surgery/serial casting / botulinum toxin injection scheduled during the study period. Other medications can be continued as prescribed by the participants' physician.
- Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention.
- Uncontrolled seizures or epilepsy
Sites / Locations
- University Children's Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1: 12 weeks functional exercise training followed by standard therapy
Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training
Arm Description
12 weeks functional exercise training twice per week, each session lasting 60 min, additionally to standard therapy. Training sessions will be performed in a group-setting consisting of minimum 4 and maximum 8 participants and coached by experienced sport scientists with the supervision of a medical doctor. The exercises will be individually pants and constantly recorded in order to allow a progression over the course of the 12 week-period. The motor tasks and exercises will be tailored to individual capacity by experienced and trained sport scientists and coaches, therefore insuring the participants' safety and a continuous and progressive monitoring of training load. After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks.
12 weeks standard therapy / treatment; the standard therapy group receives no additional exercise sessions. After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks. After 12 weeks the groups will switch the intervention method. Group 2 will perform the same intervention which Group 1 received over the first course of 12 weeks.
Outcomes
Primary Outcome Measures
Change in Gross Motor Function Measure-66 (GMFM-66)
assessment tool designed to measure changes in gross motor function over time in children and adolescents with CP. The test consist of the following five dimensions which span the spectrum of gross motor activities: a) lying and rolling; b) sitting; c) crawling and kneeling; d) standing; e) walking, running and jumping. Scores range from 0-3, higher scores denote better performance
Secondary Outcome Measures
Change in height of participants
Change in height of participants will be measured in an upright standing position without shoes using a wall-mounted stadiometer
Change in body composition
Change in body composition will be measured by bioelectrical impedance analysis (BIA) using the InBody 270 (InBody Europe B.V., Eschorn, Germany) device
Change in clinical assessment
Clinical assessment will be performed for active ankle dorsiflexion, passive range of motion (RoM), spasticity according to the modified Ashworth/Bohannon scale (scale: 0-4). Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity.
Change in muscle strength test (scale: 0-5)
Change in muscle strength test (scale: 0-5) : 0/5 = No visible muscle contraction. 5/5: Full strength
Change in arterial stiffness
Measurement of arterial stiffness using the oscillometric method. The mean values of three valid measurements will be calculated
Change in Six-minute walking test
The six-minute walking test will be performed between 2 lines set 20m apart. Participants will be instructed to walk as far as possible in 6 minutes.Total distance covered in six minutes as well as heart rate will be recorded.
Change in Handgrip Strength
Handgrip strength will be assessed using the Leonardo Mechanography GF®. Participants will be asked to hold their writing hand in a 90-degree angle and to squeeze the sensor as hard as possible for a total of 5 s. Participants will perform two valid measurements with 1 min rest in between. Peak strength in N as well as rate of force development (RFD) will be extracted.
Change in Bear Hug Carry
The bear hug carry will be performed carrying a medicine ball over a 100m distance. Two lines will be marked 20m apart and participants will be asked to walk the distance 5 times as fast as they can while holding the weighted ball in front of their chest. Participants at pre-measurement will be asked to carry the lightest ball (4 lbs). The same weight will be used in M2 as well as in M3 and the duration to walk the distance (in seconds) will be recorded. An additional test at M2 und M3 will be proposed, in which participants may choose an-other weight if they believe to be able to increase the load and repeat the test. This allows the measurement of individual increase in activity capacity. Weight and time will be recorded.
Change in Laying on the ground and standing up (burpees)
Individuals are to fully lay on the floor (hands, chest and feet) and stand or jump back up (full extension in hips and knees). The total number of repetitions over 60 seconds will be recorded
Change in Repeated Chair Rising Test (Box Squats):
The repeated chair rising test will be performed on a force plate (Leonardo Mechanography GF®, Novotec Medical GmbH, Pforzheim, Germany) with a 46cm high locked bench. Starting from a seated position, arms crossed in front of the chest, participants will perform five complete sit-to-stand cycles as fast as possible. Total time of the five repetitions as well as relative power and mean velocity for a cycle will be analyzed
Change in Isometric Mid-thigh pull
Isometric Mid-thigh pull (IMTP) is a multi-joint test which measures isometric force and rate of force development (RFD) in the back as well as lower body muscles and is strongly correlated to dynamic performance. Participants will be instructed to pull as fast and as hard as possible for a duration of 5 seconds
Change in Push Ups
The push up measures upper body strength (m. triceps brachii, m. pectoralis) and reflects the participants' ability to press and control their own body weight. For a full repetition, participants must start with their arms extended, touch the ground with their chest, and press back into an extended position. To find their 6 Repetition maximum (RM), participants will position their hands on a box with their feet on the floor. As in the squat depth test, depth of the boxes increase in a 10 cm increment. The lower the boxes, the more body weight is transferred on the upper body and must be pressed. Three minutes rest will be granted between trials to ensure complete recovery. The lowest box (or floor) on which 6 full repetitions can be performed will be noted. Box height and increase of active ROM will be analyzed.
Change in Medicine Ball over Bar Lift
This test measures the ability to lift and heave an object over an obstacle and allows a high trans-fer into daily life (i.e. lifting groceries onto a table or counter). Participants will lift a medicine ball from the ground and drop it over a bar installed in a rack at chest height as many times as possi-ble over 60 seconds, whereby testing personnel will roll the ball back in front of participants feet after every repetition. Weight of MB will be determined individually at M1 and corresponds to a 6 RM (whereby the lightest weight is a 4 lbs ball and the heaviest a 30 lbs medicine ball). Number of repetitions in the given time will be recorded. At M2 and M3, test will be repeated with the same medicine ball. Additionally, a new 6 RM will be determined and in the case of an increase in weight the test will be repeated with the new weight. Weight and number of repetitions will be recorded and increase in work capacity will be calculated.
Change in Seated sled pull
To assess participants' strength capacity in pulling strength, seated sled pulls will be performed. From a seated position, participants will pull a weighted sled over 20m using their upper body. Participants must pull the entire rope length (20m) without interruption in order for it to be counted as valid. The resistance (weight on the sled) will be increased in every round until failure (cannot pull rope or pull is interrupted). Weight and time of every round will be recorded.
Change in Maximum Power Output
Maximum power output and anaerobic capacity will be measured on an Assault Bike (Assault AirBike Classic ®, Ostfildern, Germany). Participants will perform a 1-minute all-out test. The resistance increases in line with rotations per minute (RPM). Participants will be instructed to go as hard as they can for the entire minute. Maximum heartrate and mean watt will be recorded and relative watt calculated to measure maximum power output.
Change in Accelerometry
In order to examine whether the intervention increases activity in daily life, patients will be asked to wear an Actigraph wGT3X-BT around their non-dominant wrist for 7 consecutive days and nights during each measuring phase. This triaxial accelerometer records intensity and duration of acceleration and converts the signals to "activity counts", allowing an analysis of duration and intensity of movement patterns during everyday life.
Change in instrumented gait analysis: temporospatial parameters
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the temporospatial parameters (cadence, stride length, and walking speed) can be calculated.
Change in instrumented gait analysis: Movement Analysis Profile (MAP)
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the Movement Analysis Profile (MAP) can be calculated.
Change in instrumented gait analysis: Profile Score (GPS)
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the Gait Profile Score (GPS) can be calculated.
Full Information
NCT ID
NCT04911309
First Posted
May 26, 2021
Last Updated
January 17, 2023
Sponsor
University Children's Hospital Basel
Collaborators
Béatrice Ederer-Weber Stiftung, Schweizerische Stiftung für das cerebral gelähmte Kind
1. Study Identification
Unique Protocol Identification Number
NCT04911309
Brief Title
Functional Exercise Training With Adolescents With Cerebral Palsy
Official Title
Functional Exercise Intervention With Adolescents With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital Basel
Collaborators
Béatrice Ederer-Weber Stiftung, Schweizerische Stiftung für das cerebral gelähmte Kind
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This cross-over study analyzes a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.
It is to investigate the effects of a functional movement-based exercise intervention in a group setting on motor capacity, motor capability and quality of life in adolescents with CP compared to standard therapy.
Detailed Description
Cerebral palsy (CP) is a permanent disorder which affects the development of movement and posture. It causes activity limitation and is oftentimes accompanied by secondary musculoskeletal problems, disturbances of sensation, perception, cognition, communication and behavior.
In regard of the complex interplay between physical restrictions, motor disabilities, sedentary lifestyles and low participation in physical activity, an innovative exercise intervention study for adolescents with CP is intended in order to break the stated vicious cycle. This study aims at providing a novel and inclusive approach in how therapy for adolescents with CP is administered, with the main goal of examining the effects of a functional exercise intervention on motor capability and motor capacity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
adolescents with cerebral palsy, functional exercise intervention, motor capability, motor capacity, gross motor function measure (GMFM-66)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is designed as a two-armed crossover intervention study with two intervention phases lasting 12 weeks each and three measurement points.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: 12 weeks functional exercise training followed by standard therapy
Arm Type
Active Comparator
Arm Description
12 weeks functional exercise training twice per week, each session lasting 60 min, additionally to standard therapy. Training sessions will be performed in a group-setting consisting of minimum 4 and maximum 8 participants and coached by experienced sport scientists with the supervision of a medical doctor. The exercises will be individually pants and constantly recorded in order to allow a progression over the course of the 12 week-period. The motor tasks and exercises will be tailored to individual capacity by experienced and trained sport scientists and coaches, therefore insuring the participants' safety and a continuous and progressive monitoring of training load.
After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks.
Arm Title
Group 2: 12 weeks standard therapy / treatment followed by 12 weeks functional exercise training
Arm Type
Active Comparator
Arm Description
12 weeks standard therapy / treatment; the standard therapy group receives no additional exercise sessions. After 12 weeks the groups will switch the intervention method. Group 1 will therefore reassume their standard therapy for 12 weeks.
After 12 weeks the groups will switch the intervention method. Group 2 will perform the same intervention which Group 1 received over the first course of 12 weeks.
Intervention Type
Other
Intervention Name(s)
functional exercise training
Intervention Description
12 weeks functional exercise training twice per week, each session lasting 60 min
Intervention Type
Other
Intervention Name(s)
standard therapy / treatment
Intervention Description
12 weeks standard therapy / treatment
Primary Outcome Measure Information:
Title
Change in Gross Motor Function Measure-66 (GMFM-66)
Description
assessment tool designed to measure changes in gross motor function over time in children and adolescents with CP. The test consist of the following five dimensions which span the spectrum of gross motor activities: a) lying and rolling; b) sitting; c) crawling and kneeling; d) standing; e) walking, running and jumping. Scores range from 0-3, higher scores denote better performance
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary Outcome Measure Information:
Title
Change in height of participants
Description
Change in height of participants will be measured in an upright standing position without shoes using a wall-mounted stadiometer
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in body composition
Description
Change in body composition will be measured by bioelectrical impedance analysis (BIA) using the InBody 270 (InBody Europe B.V., Eschorn, Germany) device
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in clinical assessment
Description
Clinical assessment will be performed for active ankle dorsiflexion, passive range of motion (RoM), spasticity according to the modified Ashworth/Bohannon scale (scale: 0-4). Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in muscle strength test (scale: 0-5)
Description
Change in muscle strength test (scale: 0-5) : 0/5 = No visible muscle contraction. 5/5: Full strength
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in arterial stiffness
Description
Measurement of arterial stiffness using the oscillometric method. The mean values of three valid measurements will be calculated
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Six-minute walking test
Description
The six-minute walking test will be performed between 2 lines set 20m apart. Participants will be instructed to walk as far as possible in 6 minutes.Total distance covered in six minutes as well as heart rate will be recorded.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Handgrip Strength
Description
Handgrip strength will be assessed using the Leonardo Mechanography GF®. Participants will be asked to hold their writing hand in a 90-degree angle and to squeeze the sensor as hard as possible for a total of 5 s. Participants will perform two valid measurements with 1 min rest in between. Peak strength in N as well as rate of force development (RFD) will be extracted.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Bear Hug Carry
Description
The bear hug carry will be performed carrying a medicine ball over a 100m distance. Two lines will be marked 20m apart and participants will be asked to walk the distance 5 times as fast as they can while holding the weighted ball in front of their chest. Participants at pre-measurement will be asked to carry the lightest ball (4 lbs). The same weight will be used in M2 as well as in M3 and the duration to walk the distance (in seconds) will be recorded. An additional test at M2 und M3 will be proposed, in which participants may choose an-other weight if they believe to be able to increase the load and repeat the test. This allows the measurement of individual increase in activity capacity. Weight and time will be recorded.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Laying on the ground and standing up (burpees)
Description
Individuals are to fully lay on the floor (hands, chest and feet) and stand or jump back up (full extension in hips and knees). The total number of repetitions over 60 seconds will be recorded
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Repeated Chair Rising Test (Box Squats):
Description
The repeated chair rising test will be performed on a force plate (Leonardo Mechanography GF®, Novotec Medical GmbH, Pforzheim, Germany) with a 46cm high locked bench. Starting from a seated position, arms crossed in front of the chest, participants will perform five complete sit-to-stand cycles as fast as possible. Total time of the five repetitions as well as relative power and mean velocity for a cycle will be analyzed
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Isometric Mid-thigh pull
Description
Isometric Mid-thigh pull (IMTP) is a multi-joint test which measures isometric force and rate of force development (RFD) in the back as well as lower body muscles and is strongly correlated to dynamic performance. Participants will be instructed to pull as fast and as hard as possible for a duration of 5 seconds
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Push Ups
Description
The push up measures upper body strength (m. triceps brachii, m. pectoralis) and reflects the participants' ability to press and control their own body weight. For a full repetition, participants must start with their arms extended, touch the ground with their chest, and press back into an extended position. To find their 6 Repetition maximum (RM), participants will position their hands on a box with their feet on the floor. As in the squat depth test, depth of the boxes increase in a 10 cm increment. The lower the boxes, the more body weight is transferred on the upper body and must be pressed. Three minutes rest will be granted between trials to ensure complete recovery. The lowest box (or floor) on which 6 full repetitions can be performed will be noted. Box height and increase of active ROM will be analyzed.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Medicine Ball over Bar Lift
Description
This test measures the ability to lift and heave an object over an obstacle and allows a high trans-fer into daily life (i.e. lifting groceries onto a table or counter). Participants will lift a medicine ball from the ground and drop it over a bar installed in a rack at chest height as many times as possi-ble over 60 seconds, whereby testing personnel will roll the ball back in front of participants feet after every repetition. Weight of MB will be determined individually at M1 and corresponds to a 6 RM (whereby the lightest weight is a 4 lbs ball and the heaviest a 30 lbs medicine ball). Number of repetitions in the given time will be recorded. At M2 and M3, test will be repeated with the same medicine ball. Additionally, a new 6 RM will be determined and in the case of an increase in weight the test will be repeated with the new weight. Weight and number of repetitions will be recorded and increase in work capacity will be calculated.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Seated sled pull
Description
To assess participants' strength capacity in pulling strength, seated sled pulls will be performed. From a seated position, participants will pull a weighted sled over 20m using their upper body. Participants must pull the entire rope length (20m) without interruption in order for it to be counted as valid. The resistance (weight on the sled) will be increased in every round until failure (cannot pull rope or pull is interrupted). Weight and time of every round will be recorded.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Maximum Power Output
Description
Maximum power output and anaerobic capacity will be measured on an Assault Bike (Assault AirBike Classic ®, Ostfildern, Germany). Participants will perform a 1-minute all-out test. The resistance increases in line with rotations per minute (RPM). Participants will be instructed to go as hard as they can for the entire minute. Maximum heartrate and mean watt will be recorded and relative watt calculated to measure maximum power output.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in Accelerometry
Description
In order to examine whether the intervention increases activity in daily life, patients will be asked to wear an Actigraph wGT3X-BT around their non-dominant wrist for 7 consecutive days and nights during each measuring phase. This triaxial accelerometer records intensity and duration of acceleration and converts the signals to "activity counts", allowing an analysis of duration and intensity of movement patterns during everyday life.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in instrumented gait analysis: temporospatial parameters
Description
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the temporospatial parameters (cadence, stride length, and walking speed) can be calculated.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in instrumented gait analysis: Movement Analysis Profile (MAP)
Description
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the Movement Analysis Profile (MAP) can be calculated.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Title
Change in instrumented gait analysis: Profile Score (GPS)
Description
Change in instrumented gait analysis using a motion capture system. Participants will be asked to walk a distance of about 8 m at their self-selected speed. From the 3D gait data, the Gait Profile Score (GPS) can be calculated.
Time Frame
at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CP.
Adolescents between 12 and 18 years of age.
Gross Motor Functional Classification System (GMFCS): I-III.
Cognitive abilities must include: Ability to actively engage in a training session of 60 min. duration; Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend training, testing and follow-up sessions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.
Exclusion Criteria:
Any surgery or botulinum toxin treatment within 6 months prior to the start of the study or surgery/serial casting / botulinum toxin injection scheduled during the study period. Other medications can be continued as prescribed by the participants' physician.
Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention.
Uncontrolled seizures or epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Viehweger, Prof. Dr. med.
Organizational Affiliation
Childrens University Hospital Basel (UKBB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Basel
City
Basel
ZIP/Postal Code
4056
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Functional Exercise Training With Adolescents With Cerebral Palsy
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