Functional Exercise Training With Adolescents With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Functional Exercise Intervention With Adolescents With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911309
• Other study ID #: 2020-02827; ks20Klaeusler
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: January 2023
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• functional exercise training
12 weeks functional exercise training twice per week, each session lasting 60 min
• standard therapy / treatment
12 weeks standard therapy / treatment

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Children's Hospital Basel	Béatrice Ederer-Weber Stiftung, Schweizerische Stiftung für das cerebral gelähmte Kind

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	Change in arterial stiffness	Measurement of arterial stiffness using the oscillometric method. The mean values of three valid measurements will be calculated	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)
Secondary	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.	at baseline (M1), at week 12 (M2: after intervention phase 1) and at week 24 (M3: after intervention phase 2)