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The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Qualitative functional therapy
Functional therapy
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. spastic type of CP
  2. bilateral motor involvement (both diplegia and quadriplegia)
  3. GMFCS-level II and III
  4. 6 to 12 years old
  5. cognition: able to understand and execute instructions in a proper way and sufficient concentration (both during the measurements as during the camp).

Exclusion Criteria:

  1. mixed form of CP (with ataxia or dystonia)
  2. Botulinum Toxin-A injections within six months prior to the camp
  3. multilevel orthopedic surgery within one year prior to the camp
  4. selective dorsal rhizotomy within two years prior to the camp
  5. spinal fusion

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

Intensive qualitative functional therapy

Intensive functional therapy

Outcomes

Primary Outcome Measures

Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)
The Gross Motor Function Measure (GMFM)25 is used for the evaluation of gross motor function. The GMFM-88 exists of 88 items categorized into five dimensions: Lying & Rolling (Dim A), Sitting (Dim B), Crawling & Kneeling (Dim C), Standing (Dim D), and Walking, Running & Jumping (Dim E). The Quality Function Measure (QFM)26 evaluates the quality of execution of the items of Dim D and E of the GMFM. Five attributes are scored separately by use of video scoring: alignment, coordination, weight shift, stability and dissociated movements. GMFM: scale ranges fo each item: 0-3 (0 is the minimum score, 3 is the maximum score). There is a total score for all dimensions and a subscore for each dimension, expressed in a percentage. QFM: scale ranges for each qualitative attribute: 0-3 (0 is the minimum score, 3 the maximum score). There is a total score for each qualitative attribute.

Secondary Outcome Measures

3D-motion analysis system movements of lower limbs and trunk during gait
3D-movement analysis is used to evaluate lower limb and trunk movements during gait. The children walk barefoot over a 10m walkway at self-selected speed, while marker trajectories on trunk and lower limbs are captured by 12 infrared cameras (VICON system). Spatiotemporal and kinematic parameters will be evaluated.
Range of motion (passive and active)
Assessed with a goniometer (degrees) in standardised positions.
Timed Up and Go
Assesses dynamic balance and mobility of the child.
1 Minute Walking Test
Evaluates walking ability and endurance of the child.
Muscle tone
Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).
Muscle strength
Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).
Trunk Control Measurement Scale
Trunk control in sitting is evaluated with the Trunk Control Measurement Scale (TCMS). The TCMS evaluates two prime aspects of trunk control during functional activities: (1) being a stable base for upper and lower limb movements, and (2) being an actively moving body segment. It consists of three subscales: 'static sitting balance', 'selective movement control' and 'dynamic reaching'. Scale range: 0-3 (0 is the minimum score, 3 is the maximum score).

Full Information

First Posted
February 22, 2018
Last Updated
October 17, 2019
Sponsor
University Ghent
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03449498
Brief Title
The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Official Title
The Effects of Intensive Therapy on Quantitative and Qualitative Parameters of Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ghent
Collaborators
KU Leuven

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
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent. This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.
Detailed Description
Research on the effects of physiotherapeutic interventions in children with CP has grown expansively, and shows a wide diversity of techniques and concepts that are used in variable intensity. Until now there is no consensus on the optimal intensity of these interventions to have a positive impact on the activity and participation level of these children. A recent systematic review and meta-analysis already showed evidence for the effect of intensive training of hand function in children with CP, including short bursts of highly intensive therapy. In contrast, studies on the effect of intensive therapy of gross motor function were limited, and training was performed at a lower intensity during a longer period, resulting in effects that are more inconclusive. Moreover, none of the reviewed studies included improvement of trunk control as one of their treatment goals, although it is known that most children with CP experience some problems with trunk control, to a variable extent. This research project has two aims, i.e. 1) investigating the effect of intensive therapy camps on qualitative and quantitative parameters of lower limbs and trunk; and 2) comparing the effect of two therapeutic approaches, namely a functional approach versus a more qualitative-functional approach on these parameters.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
Intensive qualitative functional therapy
Arm Title
control group
Arm Type
Experimental
Arm Description
Intensive functional therapy
Intervention Type
Other
Intervention Name(s)
Qualitative functional therapy
Intervention Description
Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Six functional activities focusing on lower limbs and trunk are performed: walking, stair climbing, balance, transfers, trunk control, and Wii (combination of functional activities in sitting and/or standing). A group of clinical experts composes a set of exercises for each of these activities, however individual adaptations according to the needs and abilities of the child can be still be done. Quality of movement (alignment, weightshift, dissociation, coordination and stability) is hereby very important. The theme 'circus' is used to enhance the motivation of the children.
Intervention Type
Other
Intervention Name(s)
Functional therapy
Intervention Description
Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Goals are set with the parents and the children. During the camp children work on obtaining these goals in a exclusively functional way.
Primary Outcome Measure Information:
Title
Quality Function Measurement (QFM) and the Gross Motor Measurement Scale (GMFM)
Description
The Gross Motor Function Measure (GMFM)25 is used for the evaluation of gross motor function. The GMFM-88 exists of 88 items categorized into five dimensions: Lying & Rolling (Dim A), Sitting (Dim B), Crawling & Kneeling (Dim C), Standing (Dim D), and Walking, Running & Jumping (Dim E). The Quality Function Measure (QFM)26 evaluates the quality of execution of the items of Dim D and E of the GMFM. Five attributes are scored separately by use of video scoring: alignment, coordination, weight shift, stability and dissociated movements. GMFM: scale ranges fo each item: 0-3 (0 is the minimum score, 3 is the maximum score). There is a total score for all dimensions and a subscore for each dimension, expressed in a percentage. QFM: scale ranges for each qualitative attribute: 0-3 (0 is the minimum score, 3 the maximum score). There is a total score for each qualitative attribute.
Time Frame
1h30
Secondary Outcome Measure Information:
Title
3D-motion analysis system movements of lower limbs and trunk during gait
Description
3D-movement analysis is used to evaluate lower limb and trunk movements during gait. The children walk barefoot over a 10m walkway at self-selected speed, while marker trajectories on trunk and lower limbs are captured by 12 infrared cameras (VICON system). Spatiotemporal and kinematic parameters will be evaluated.
Time Frame
1h
Title
Range of motion (passive and active)
Description
Assessed with a goniometer (degrees) in standardised positions.
Time Frame
10 minutes
Title
Timed Up and Go
Description
Assesses dynamic balance and mobility of the child.
Time Frame
5 minutes
Title
1 Minute Walking Test
Description
Evaluates walking ability and endurance of the child.
Time Frame
5 minutes
Title
Muscle tone
Description
Modified Ashworth Scale, Tardieu Scale. Scale ranges: 0-4 (0 is the maximum score, 4 is the minimum score).
Time Frame
10 minutes
Title
Muscle strength
Description
Daniels and Worthingham's Manual Muscle Testing. Scale ranges: 0-5 (0 is the minimum score, 5 is the maximum score).
Time Frame
10 minutes
Title
Trunk Control Measurement Scale
Description
Trunk control in sitting is evaluated with the Trunk Control Measurement Scale (TCMS). The TCMS evaluates two prime aspects of trunk control during functional activities: (1) being a stable base for upper and lower limb movements, and (2) being an actively moving body segment. It consists of three subscales: 'static sitting balance', 'selective movement control' and 'dynamic reaching'. Scale range: 0-3 (0 is the minimum score, 3 is the maximum score).
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: spastic type of CP bilateral motor involvement (both diplegia and quadriplegia) GMFCS-level II and III 6 to 12 years old cognition: able to understand and execute instructions in a proper way and sufficient concentration (both during the measurements as during the camp). Exclusion Criteria: mixed form of CP (with ataxia or dystonia) Botulinum Toxin-A injections within six months prior to the camp multilevel orthopedic surgery within one year prior to the camp selective dorsal rhizotomy within two years prior to the camp spinal fusion
Facility Information:
Facility Name
Ghent University
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Intensive Therapy on Trunk and Lower Limbs in Children With Spastic Cerebral Palsy.

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