Effect of Whirlpool Therapy Combined With Botulinum Toxin in Children With Cerebral Palsy
Investigation of the Effects of Combining Whirlpool Therapy With Botulinum Toxin Treatment on Spasticity, Gait, and Motivation in Children With Cerebral Palsy
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
Outcome measures were assessed at three time points: baseline (T0, week 0, pre-treatment), post-treatment (T1, week 4), and follow-up (T2, week 12). Spasticity was evaluated using the Modified Ashworth Scale (MAS) and the Modified Tardieu Scale (MTS). Functional mobility and standing/walking abilities were assessed using the Gross Motor Function Measure-88 (GMFM-88) dimensions D and E. Motivation was evaluated using the Pediatric Motivation Scale. Gait kinematics, including joint range of motion and peak flexion and extension angles of the hip, knee, and ankle, were analyzed using the DIERS 4D Motion Lab system. Functional walking performance was assessed using the 10-Meter Walk Test (10MWT).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06010
- Ankara Etlik City Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Botulinum Toxin + Conventional Physiotherapy + Whirlpool Therapy
Patients receiving 4 weeks of conventional physical therapy combined with whirlpool therapy (20 minutes per session, 3 times per week).
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Standard rehabilitation program including range of motion exercises, stretching, strengthening, balance, coordination, endurance, and gait training, 5 days per week for 4 weeks under physiotherapist supervision.
Whirlpool therapy administered 3 times per week for 4 weeks, 20 minutes per session (total 12 sessions), in addition to conventional rehabilitation.
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활성 비교기: Botulinum Toxin + Conventional Physiotherapy
Patients receiving 4 weeks of conventional physical therapy alone.
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Standard rehabilitation program including range of motion exercises, stretching, strengthening, balance, coordination, endurance, and gait training, 5 days per week for 4 weeks under physiotherapist supervision.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gross Motor Function Measure-88 (GMFM-88) - Dimension E (Walking, Running and Jumping)
기간: Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)
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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.
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Baseline (Week 0), Week 4 (post-treatment), Week 12 (follow-up)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Modified Ashworth Scale (MAS)
기간: Week 0, Week 4, Week 12
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Spasticity was assessed using the MAS.
Scores were recorded for the hamstring, gastrocnemius, and adductor muscles of the affected side.
The MAS is a 6-point ordinal scale (0, 1, 1+, 2, 3, and 4) used to assess resistance to passive movement, with higher scores indicating greater muscle spasticity.
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Week 0, Week 4, Week 12
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Pediatric Motivation Scale
기간: Week 4, Week 12
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Motivation was assessed using the Pediatric Motivation Scale (PMS), a validated self-report instrument designed to evaluate children's motivation toward rehabilitation.
The scale consists of 21 items and includes six domains: effort-importance, interest-enjoyment, competence, relatedness, autonomy, and value-usefulness.
The first 19 items are rated on a 6-point Likert scale ranging from 1 ("not at all true") to 6 ("very true"), while the remaining two items are open-ended questions.
Total and domain scores are calculated from the Likert-scale items.
Higher scores indicate greater motivation, stronger engagement in rehabilitation activities, and a higher degree of internally regulated motivation.
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Week 4, Week 12
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DIERS 4D Motion Analysis System
기간: Baseline (Week 0), Week 4, Week 12
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Three-dimensional gait kinematics were assessed using the DIERS 4D motion analysis system.
Maximum hip, knee, and ankle flexion and extension angles of the hemiparetic limb were recorded.
Additionally, bilateral knee valgus and varus angles were measured during gait.
All data were automatically stored in the system memory for further analysis.
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Baseline (Week 0), Week 4, Week 12
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10-Meter Walk Test (10MWT)
기간: Baseline (Week 0), Week 4, Week 12
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Walking performance was assessed using the 10MWT.
Participants walked a 10-meter straight path at their comfortable walking speed.
Time was recorded in seconds, and gait speed (m/s) and cadence (steps/min) were calculated.
Two trials were performed, and the best performance was recorded.
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Baseline (Week 0), Week 4, Week 12
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Gross Motor Function Measure-88 (GMFM-88) - Dimension D (Standing)
기간: Baseline (Week 0), Week 4, Week 12
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The GMFM-88 Dimension D was used to assess standing ability in children with hemiplegic cerebral palsy.
This domain consists of 13 items evaluating static and dynamic standing activities.
Each item is scored on a 4-point scale (0-3), and raw scores are converted to percentage values (0-100) based on the maximum achievable score.
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Baseline (Week 0), Week 4, Week 12
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Modified Tardieu Scale (MTS)
기간: Week 0, Week 4, Week 12
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Spasticity was assessed using the MTS for the hamstring and gastrocnemius muscles of the affected side.
Passive movement was performed at V1 (slow velocity) and V3 (fast velocity).
Muscle reaction quality, R1, R2, and R2-R1 values were recorded.
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Week 0, Week 4, Week 12
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: DAMLA CANKURTARAN, MD, Ankara Etlik City Hospital
연구 기록 날짜
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추가 정보
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추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- AEŞH-EK1-2025-046
개별 참가자 데이터(IPD) 계획
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