Investigation of the Effects of Combining Whirlpool Therapy With Botulinum Toxin Treatment on Spasticity, Gait, and Motivation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping)
研究概览
简要总结
This study aims to investigate the effects of adding whirlpool therapy to standard rehabilitation in children with cerebral palsy who recently received botulinum toxin-A injections. Participants will be divided into two groups: one group will receive standard physiotherapy, while the other group will receive physiotherapy combined with whirlpool therapy. The effects of these interventions on spasticity, gait function, and motivation will be evaluated over a 12-week follow-up period.
详细描述
This study was designed as a prospective, randomized, single-blind (assessor-blinded), parallel-group controlled clinical trial investigating the effects of combining whirlpool therapy with botulinum toxin type A (BoNT-A)-assisted rehabilitation on spasticity, gait, and motivation in children with hemiplegic cerebral palsy.
A total of 81 patients with hemiplegic cerebral palsy who had received botulinum toxin type A (BoNT-A) injections to selected lower extremity muscles within the previous week were initially evaluated. After applying the inclusion and exclusion criteria, 43 participants were enrolled in the study, and 38 patients were excluded. All botulinum toxin injections were performed using onabotulinumtoxinA by an experienced physiatrist with more than five years of clinical experience. Injection planning was individualized according to body weight, severity of spasticity, and targeted muscle groups.
Participants were randomly assigned in a 1:1 ratio to two groups (22 in the intervention group and 21 in the control group). Randomization was performed using a computer-generated random sequence by an independent researcher who was not involved in treatment or assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. The study was conducted as a single-blind trial in which the outcome assessors were blinded to group allocation, while participants and therapists were not blinded because of the nature of the intervention.
Both groups received a conventional rehabilitation program for 4 weeks, 5 days per week, 1 hour per day. The program included range of motion (ROM) exercises for the upper and lower extremities, stretching and strengthening exercises, balance and coordination training, endurance exercises, and ambulation training, all delivered under physiotherapist supervision according to a standardized protocol.
In addition to conventional rehabilitation, the intervention group received whirlpool therapy three times per week for 4 weeks, with each session lasting 20 minutes, for a total of 12 sessions. All whirlpool therapy sessions were conducted under physiotherapist supervision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation. Participants and physiotherapists were not blinded due to the nature of the intervention. Group assignments were concealed from evaluators during all assessments and data analyses were performed using coded group labels.
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemiplegic cerebral palsy
- •Age between 3 and 10 years
- •Gross Motor Function Classification System (GMFCS) levels I-II
- •Sufficient cognitive level to follow instructions
- •Ability to walk at least 10 meters with an orthosis and/or walking aid
- •Receipt of botulinum toxin injection to the lower extremity within the past week
- •Ability to walk independently for 1 minute without orthosis or assistive device
排除标准
- •Uncontrolled epilepsy
- •Urinary incontinence
- •Presence of lower extremity contractures
- •History of previous orthopedic surgery
- •Presence of hip subluxation
- •Ataxic or dyskinetic cerebral palsy
- •History of any botulinum toxin injection within the 6 months prior to the current 1-week post-injection period
- •Inability to cooperate during clinical assessments
结局指标
主要结局
Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping)
时间窗: Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)
The primary outcome measure was the Gross Motor Function Measure-88 (GMFM-88) Dimension E, which evaluates walking, running, and jumping abilities in children with hemiplegic cerebral palsy. Each item is scored on a 4-point scale (0-3), and raw scores are converted to percentage values (0-100). Dimension E consists of 24 items, with a maximum raw score of 72 points.
次要结局
- Modified Ashworth Scale (MAS)(Week 0, Week 4, Week 12)
- Pediatric Motivation Scale(Week 4, Week 12)
- DIERS 4D Motion Analysis System(Baseline (Week 0), Week 4, Week 12)
- 10-Meter Walk Test (10MWT)(Baseline (Week 0), Week 4, Week 12)
- Gross Motor Function Measure-88 (GMFM-88) - Dimension D (Standing)(Baseline (Week 0), Week 4, Week 12)
- Modified Tardieu Scale (MTS)(Week 0, Week 4, Week 12)
研究者
AYŞENUR GENÇER ÖZTÜRK
Resident Physician
Ankara Etlik City Hospital