In Our Prospective and Randomized Controlled Study, 42 Children With Unilateral Cerebral Palsy Were Included and Randomized as the mCIMT Group Delivered Via Telerehabilitation (n=21) and the Control Group (n=21). The First Group Received mCIMT Treatment Together With Telerehabilitation for 1 Hour, 3 Times a Week for 6 Weeks. In Addition, 30 Minutes of Indoor Activity Practices Were Performed Every Day. The Second Group Received a Home Program Under the Supervision of Parents for 1 Hour, 3 Times a Week for 6 Weeks.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Assisting Hand Assessment
研究概览
简要总结
Aim:In this prospective and randomized controlled thesis study; we aimed to compare Modified Constraint-Induced Movement Therapy (mCIMT) delivered via Telerehabilitation with the home program in children with Unilateral Cerebral Palsy (CP) and to determine whether Telerehabilitation has a positive effect on upper extremity functions and quality of life.
Method: In our prospective and randomized controlled study, 42 children with unilateral cerebral palsy were included and randomized as the mCIMT group delivered via Telerehabilitation (n=21) and the control group (n=21).
The first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day.
The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks.
.In the randomized double-blind study, initial assessments, post-treatment and follow-up assessments were performed by the researcher who was blinded to the group distribution.
The primary outcome measure was the Assisting Hand Assessment (AHA), which was used to evaluate upper extremity function. The researcher administering this assessment was blinded to group allocation. Secondary outcome measures included the Modified Jebsen Taylor Hand Function Test, range of motion assessed with a goniometer, spasticity evaluated using the Modified Ashworth Scale, grip strength measured with a Jamar dynamometer, manual ability classified using the Manual Ability Classification System (MACS), activities of daily living assessed by ABILHAND-Kids, and quality of life evaluated using the KINDL questionnaire.
Post-treatment assessments were performed at the beginning of the study and 6 weeks after treatment.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion between the ages of 4-12
- •Diagnosis of unilateral CP by a specialist
- •Ability to extend the suspected wrist more than 10°
- •Demonstration of ability to follow simple commands and participation in assigned tasks
- •Gross Motor Function Classification System Level 1 or 2
- •Manual Skills Classification System Level 1, 2 or 3
- •Muscle tone is normal/mild/moderate (Modified Ashworth Scale level 0-1-2)
- •No contractures in the upper extremity
- •Agrees to attend intensive therapy sessions and to stop all other upper extremity therapeutic interventions for the 3-month follow-up period
排除标准
- •Significant contractures in the wrist, elbow, and fingers that prevent daily activities
- •Lack of active movement in the affected upper extremity
- •Cognitive impairment that causes inability to understand and perform simple commands and tasks
- •Inability to continue treatment protocol due to school schedule
- •Uncontrolled disease (endocrinologic, cardiovascular, pulmonary, hematologic, hepatic, renal), active systemic inflammatory disease, and/or history of malignancy
- •Current or previous treatments not compatible with the study treatment protocol
- •Orthopedic surgery (tendon transfer/tendon lengthening) performed on the affected upper extremity
- •Botulinum toxin injection into upper extremity muscles within the last 6 months
- •Dorsal rhizotomy
- •Intrathecal baclofen pump
研究组 & 干预措施
via Telerehabilitation mCIMT
The first group received mCIMT treatment together with Telerehabilitation for 1 hour, 3 times a week for 6 weeks. In addition, 30 minutes of indoor activity practices were performed every day.
The second group received a home program under the supervision of parents for 1 hour, 3 times a week for 6 weeks.
干预措施: mCIMT via Telerehabilitation (Other)
home exercises control group
A 1-hour home program will be implemented 3 days a week.
干预措施: home exercise program (Other)
结局指标
主要结局
Assisting Hand Assessment
时间窗: before treatment and 6 weeks after treatment
The AHA is a test that measures how patients with upper extremity dysfunction, such as hemiplegic CP or congenital brachial plexus injury, use their affected hand in conjunction with their unaffected hand during two-handed play. It was first validated in children aged 18 months to 5 years (Small Kids AHA), and then two play tables were created for children aged 6 to 12 years (School Kids AHA). In this assessment method, a camera records the child performing tasks and playing with both hands. This assessment method can be administered by healthcare professionals who have completed the training and received certification. The test consists of two stages: first, the assessor (therapist, physician) sits opposite the child, and an environment is prepared using age-appropriate toys from the AHA kit to enable the child to perform all upper extremity functions using both hands. A camera positioned behind the assessor records this process.
次要结局
- Modified Ashworth Scale(before treatment and 6 weeks after treatment)
- ABILHAND KIDS(before treatment and 6 weeks after treatment)
- Modified Jebsen-Taylor Hand Function Test(before treatment and 6 weeks after treatment)
- Joint Range of Motion(before treatment and 6 weeks after treatment)
- Grip Strength(before treatment and 6 weeks after treatment)
- KINDL(before treatment and 6 weeks after treatment)
研究者
Mustafa Hakan KAPUCU
Medical Doctor (Res. Assist. Dr.)
Istanbul University