Children and adolescents who participate in the study will benefit from the training because their gait adaptability will improve which will have a positive effect on participation in ADL activities and their quality of life.
ID
Bron
Verkorte titel
Aandoening
Cerebral Palsy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is gait adaptability, measured with the Walking Adaptability Ladder test for Kids (WAL-K). Participants walk in a ladder of 10 meters, in which the targets decrease with 2 centimeters. The score on the WAL-K will be determined by means of completion time and failures during the task.
Achtergrond van het onderzoek
Background: Children and adolescents with Cerebral Palsy (CP) frequently experience walking problems that limit them in participation in ADL and have adverse effects on quality of life. This study is aimed at improving walking in complex, but daily situations in children and adolescents who are able to walk independently (GMFCS levels I and II). These children can usually walk quite well on uneven terrain and while being fully concentrated. However, when they have to adapt their gait to a changing environment, this may lead to problems, even for those with a high level of functioning. Quick and accurate adaptations of the walking pattern to demands of the environment is essential for safe mobility in ADL situations and during sports and play. These situations are highly prevalent in crowded classrooms, in the schoolyard, or during sports and play activities. Parents and therapists of the children in our target population have expressed the need for training specifically aimed at improving this important aspect of walking.
Design: Randomised study with an intervention and a waiting list control group.
Population: Children and adolescents with CP, GMFCS level I or II, between 6 and 17 years old.
Intervention: A walking adaptability training program (10 sessions of 45 minutes, twice a week during 5 weeks) on the C-mill. This is a treadmill with embedded force plates and projected visual context attuned to the participant’s gait pattern. The visual context evokes adjustments in foot placements. Exercises include stepping on targets with variations in step length, width and symmetry, obstacle avoidance, and following an accelerating and decelerating target area.
Primary outcome measure: Walking adaptability as measured with the Walking Adaptability Ladder test for Kids (WAL-K). Time and mistakes (touching a bar or wrong number of steps in a target) are measured.
Doel van het onderzoek
Children and adolescents who participate in the study will benefit from the training because their gait adaptability will improve which will have a positive effect on participation in ADL activities and their quality of life.
Onderzoeksopzet
This randomised study has an intervention and wait list control group. Participants will be stratified based on age category (6 to 12 years and 13 to 17 years).
After the first measurement (M1) participants will be allocated in an intervention group or wait list control group by randomasation. Participants in the intervention group directly start with the intervention. After the training of 5 weeks, both groups have the measurement again (M2). After this measurement participants in the wait list control group will start with the intervention. After the training of 5 weeks, they will have the measurement again (M3-w). Three months after the intervention the participants will have the last measurement (M4) to determine the retention of the training effects.
Onderzoeksproduct en/of interventie
Children and adolescents will participate in a training on the C-mill (Roerdink & Beek, 2009 patent MotekForcelink BV) aimed at improving their walking ability. The C-mill is a treadmill on which gait adaptations can be evoked because foot placement has to be adapted to a projected visual context. The C-mill contains a force platform, so the foot placement is registered and the performance (foot placement relative to the visual context) and different gait parameters (such as step width and length) will be determined.
The interention will focus on the gait adaptability and the automation of gait adaptability.
Based on findings in a previous study, the training will consist of 10 sessions of 45 minutes divided over 5 weeks, twice a week. Exercises will relate to correct stepping on targets with variation in step length, width and symmetry, obstacle avoidance, and response to accelerating and decelerating of the stepping targets. Every training session will end with a game in which points can be scored.
The outline and duration of the exercises during the intervention will be standardised and the same for all participants. The degree of difficulty of every exercise will be adapted to the individual ability of the participant.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age 6 to 17 years
- Spastic, dyskinetic or ataxtic Cerebral Palsy, both uni and bilateral
- GMFCS level I or II.
- Referral of the rehabilitation specialist with a question concerning walking ability
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Surgery in the last two years like SEMLS or Selective Dorsal Rhizotomy (SDR) or Intrathecal Baclofen Therapy (ITB).
- BotulinumToxin injection in the lower extremity in the last 6 months.
- If participation in training on the C-mill (a treadmill) is not possible due to for example epilepsy, severe vision problems, cognitive problems or temporary complaints affecting walking.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8154 |
Ander register | METC Arnhem Nijmegen : 2018-4223 |