The goal of the study is to enhance the participation in daily life of children with CP, by increasing their independent use of the upper limb performing daily life activities. By training the task oriented strength in daily life activities…
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Activity Level
At the activity level, measures of hand skills, bimanual performance and manual
ability will be used.
Primary outcome measure:
The Assisting Hand Assessment (AHA) measures the typical performance of a
child*s assisting hand in a range of bimanual activities. The AHA measures
ability and performance of use of the affected hand in bimanual play by
standardized video observation.
Secondary outcome
Activity Level
At the activity level, measures of hand skills, bimanual performance and manual
ability will be used.
Primary outcome measure:
The Assisting Hand Assessment (AHA) measures the typical performance of a
child*s assisting hand in a range of bimanual activities. The AHA measures
ability and performance of use of the affected hand in bimanual play by
standardized video observation.
Secondary outcome measures:
Activity Level
1. The Observation and Scoring of Arm hand Skills (OSAS) is a video-based
observation system to observe the spontaneous use of the affected limb in
standardized bimanual fine and gross motor tasks (threading beads task,
construction tasks small and large, making a sandwich tasks and stacking
cylinder tasks).
2. The ABILHAND-Kids is a 21-item questionnaire based on existing scales and
expert advice. The ABILHAND-kids is a functional scale specifically developed
to measure manual ability in children with CP (up to 12 years).
3. The Jebsen Taylor test will be used to score the velocity of the use of the
affected hand in functional standardized tasks.
Participation Level
1. The domain frequency of use of the Children's Assessment of Participation
and Enjoyment (CAPE) and Preferences for Activities for Children (PAC) will be
used to document this outcome. The CAPE/PAC has been developed to determine the
outcome on participation once per three months.
2. Enjoyment of the child during the training will be assessed using the Youth
Rating Scale of the Behavioral and Emotional Rating Scale Second Edition
(BERS-2).
Body function/Body structure
At the body function/ structure level (ICF-CY), measurement of muscle strength,
spasticity and active and passive range of movement will be performed.
1. Measurement of strength will include both dynamic and isometric components
of strength and the next tests will be performed:
a. Grip and pinch strength will be measured using the E-link from
Biometrics (isometric strength) (http://www.biometricsltd.com/REHAB.htm
b. The isometric strength of wrist and elbow muscles will be measured
using Hand Held Dynamometry (HHD). The Microfet-2 will be used, using the make
method.
(http://www.biometrics.nl/produkten.php?ms_id=196&Instrumenten/Spierkracht/Micro
FET_2.)
c. Task-oriented strength will be measured during performance of
specific tasks related to their three defined goals: two examples are the crate
task (bimanual lifting) and the measuring cup task (unimanual lifting).
Strength will be expressed as number of Kg lifted and kept in one standardized
described position for five seconds.
2. Goniometry will be used to measure an angle of catch (high velocity
stretch), presenting a measure for spasticity.45 Goniometry will also be used
to measure active and passive Range of Motion (ROM) of the wrist, elbow and
shoulder. A Lafayette Gollehon extendable goniometer (model 01335) will be
used to measure ROM. (http://www.lafayetteevaluation.com/product_detail.asp).
A standardized protocol with standardized positions will be used. The protocol
has been used in the Botulinum Toxin Bimanual Skills study (BoBiVa).
Background summary
Cerebral palsy (CP) is the most common cause of movement disability in
childhood. The incidence is 1.5-2.5 per 1000 live born children and has
remained stable over recent years. Children with CP experience limitations in
motor activities and participation in the community, predominantly caused by
impairments in muscle function. Aside from abnormal posturing due to
spasticity, muscle weakness can significantly contribute to impaired muscle
function and there is increasing evidence that muscle weakness significantly
impairs upper limb motor function and ability to perform manual tasks in
children with CP. Strength training is expected to reduce limitations in
activities of children with CP.
When strength training is applied, the guidelines of the National Strength and
Conditioning Association (NSCA) can be used.NSCA recommend training after seven
years of age. Strength training should involve a progressive intensity, thereby
stimulating strength gains that are greater than those associated with normal
growth and development. This is known as Progressive Resistance Exercise (PRE),
with a duration of at least 12 weeks. This method of strength training has
previously demonstrated efficacy in children with CP without injury or problems
with compliance during a 12-week program.
As shown, strength training focused on specific muscle groups (single joint
training) will not improve everyday activities. Furthermore, it is shown that
in the first 6-18 weeks of strength training little adaptation of muscle tissue
will occur, but mainly specific neural adaptation will take place during this
training period. Based on the strength training guideline from the NSCA , it is
concluded that motor learning theory should be incorporated into
strength-training practice. Based on both the guidelines for strength training
and the fact that neural adaption will occur mainly in the first 8-12 weeks of
training, we developed Task Oriented Arm Strength Training in children with CP
(TOAST-CP). In TOAST-CP we will perform the strength training with loaded
objects from daily life such as a bucket, a measuring cup, a belt and a crate,
to ensure the specificity of the neural adaptation for the trained activities.
In TOAST-CP the PRE training method will be used because it appeared to be a
safe training method for children with CP. No study has investigated the
effects of TOAST-CP on the performance of the activities of daily life and
strength. In contrast, usual care with specific manual skill learning program,
without any embedded strength training will be performed. The effect of
TOAST-CP on the performance of daily activities will be compared with the
effect of manual skill learning on the performance of daily activities.
Study objective
The goal of the study is to enhance the participation in daily life of children
with CP, by increasing their independent use of the upper limb performing daily
life activities. By training the task oriented strength in daily life
activities following TOAST-CP the independent use of the upper limb in bimanual
activities of daily life will increase.
Study design
A multi Centre Randomised Clinical Trial (RCT)
Intervention
After inclusion the TOAST-CP treatment will start based on the three selected
goals and an analysis of the task performance will be made of each of these
three goals. The results of the task analysis will serve as basis for the
individualized treatment of participants allocated to the TOAST-CP group. All
TOAST-CP participants will receive 30-minute contact sessions three times a
week over a 16 week period. Based on earlier research, it was established that
three goals can be trained in 30 minutes.
The control group will receive usual care, without any strength intervention,
1-3 times a week over a period of 16 weeks. Both groups will receive
individually based interventions and these interventions can be easily planned
into a regular rehabilitation schedule.
Experimental group
Task-oriented strength training protocol - TOAST-CP program-
Participants assigned to the experimental group will perform an individualized
TOAST-CP program. The exercises in TOAST-CP will be based on 1) the three
defined goals, 2) the outcome of the analysis of the task performance and 3) a
specific strength analysis will be performed based on the chosen exercises.
The Repetition Maximum (RM) model will be used to determine the load. All
exercises based on the task analysis will be loaded with weight to determine
the 10-15 RM. According to the nature of task-oriented strength exercises, a
set of muscles required to perform the functional task will be trained and
targeted. Examples of these tasks are lifting a bucket, carrying a tray, making
a sandwich, fastening a belt and lifting a mug.
The training method is Progressive Resistance Exercise (PRE). This method of
strength training has previously demonstrated efficacy in children with CP
without injury or problems with compliance during a 12-week program. Using the
NSCA guidelines, a training load of 10-15 RM, three sets with a 90-second rest
period will be used.
The PRE training lasts 16 weeks. The first two weeks consist of unloaded
task-oriented exercises, with the focus on the quality of the performance of
the task. To determine the load of 10-15 RM, measurement will take place at
conclusion of the second week. In the third and fourth week the load of the
task-oriented exercises will be increased up to the level of their individual
10-15 RM. At the start of week five, the 10-15 RM training will be started and
at conclusion of each week the load will be re-measured and adapted.
From week five to week 16 (12 weeks) the load will be increased 10-20% per
week, if a block of three sets of 10-15 RM is possible.
Control group
Usual Care (Manual Skill Learning)
Participants assigned to the control group will receive usual care (manual
skill learning).
The exercises in the control group will be based on the three defined goals.
Based on the three main goals individualized manual skill learning will be
performed, without any strength training.
Study burden and risks
Both measurement sessions and training sessions are wthout any additional
risks, compared to daily life activities, usal care and clinical investigation.
Measurement and training of strength are well known professional activities for
rehabilitation therapists and frequently used in usual care. The type of
strength training -Progressive Resistive Exercise training (PRE)- is the most
frequently used type of training, save for children and advised by the National
Strength and Conditioning Association (NSCA). The use of strength training in
upper extremity is innovative but based on PRE.
Training and measurement schedule is completely adapted to the rehabilitation
model of 30 minutes of training, 2-3 times per week, in balance with special
school schedules.
The measurements sessions will be adpated to this time schedule and will be
fitting in the daily schedule of the rehabilitation and school, without
additive time or in competition with the lessons on school.
Zandbergseweg 111
Hoensbroek 6432 CC
NL
Zandbergseweg 111
Hoensbroek 6432 CC
NL
Listed location countries
Age
Inclusion criteria
* Age 8-18 years
* Spastic Cerebral Palsy (according to the Surveillance of Cerebral Palsy in Europe
(SCPE)
* Gross Motor Function Classification System (GMFCS) I-IV
* Manual Ability Classification System (MACS) I-III
* Hand function impairment Zancolli grade I- IIB
* Children have to be able to comprehend tasks and perform the measurements and
training, judged by the rehabilitation physician of the project team. The clinical data of
the children regarding cognitive deficits and learning difficulties are available for this
study.
* Able to communicate in Dutch or English.
* * Realistic problems performing manual activities.
* Reduced upper limb strength.
* Strength difference between the left and right arm of at least 20%.
* Children and their parents indicate the necessity for improvement of the children*s
manual abilities
Exclusion criteria
* Severe impairment of hand function: no active hand function (Zancolli III)
* Upper limb hand surgery within the last six months
* Botulinum toxin-A injection of the upper limb within the last three months
* Have undertaken an upper limb specific strength training program within the last three
months
Botulinum Toxin-A or Surgery is necessary during the trial period.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL49818.015.14 |
Other | TC= 4668 |