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| Name | Class |
|---|---|
| Kayseri University | OTHER |
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This study aims to evaluate the effects of three different physiotherapy approaches-robot-assisted gait training, hydrotherapy, and conventional physiotherapy-on muscle strength, balance, functional mobility, and psychological adjustment in children diagnosed with spastic hemiparetic cerebral palsy. A total of 45 ambulatory children aged 5 to 15 years will be randomly assigned to one of the three intervention groups. All participants will receive therapy twice a week for six weeks.
Muscle strength will be assessed using a handheld dynamometer, balance with the Pediatric Balance Scale, mobility with the Timed Up and Go test, and psychological adjustment with a standardized behavioral checklist. The study will help determine which therapeutic approach provides the most benefit in improving physical function and emotional well-being. Results may guide healthcare providers and families in selecting the most effective rehabilitation method for children with cerebral palsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-Assisted Gait Training Group | Experimental | Participants in this arm will receive robot-assisted gait training using the Lokomat device for 40 minutes, twice a week, over a 6-week period. The intervention aims to improve lower limb muscle strength, balance, and mobility. |
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| Hydrotherapy Group | Experimental | Participants will undergo supervised aquatic exercises in a therapeutic pool for 40 minutes, twice a week, for 6 weeks. The exercises are designed to enhance strength, coordination, and balance in children with spastic hemiparetic cerebral palsy. |
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| Conventional Physiotherapy Group | Experimental | This group will receive conventional physiotherapy consisting of electrotherapy (faradic stimulation), passive and active range of motion exercises, gait training, and positioning techniques. Sessions last 40 minutes, twice a week, for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted gait training using Lokomat | Behavioral | This intervention involves robotic-assisted gait training with the Lokomat device. Sessions will last 40 minutes, twice a week for 6 weeks. The intervention targets lower extremity motor function in children with spastic hemiparetic cerebral palsy. The robotic system provides adjustable support and real-time feedback to improve gait patterns and mobility. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength | Change in lower extremity muscle strength measured by hand-held dynamometer (MicroFET® 2) at baseline and after 6 weeks of intervention. | Baseline and Week 6 |
| Balance | Change in balance performance assessed by Pediatric Balance Scale (PBS). | Baseline and Week 6 |
| Functional Mobility | Change in mobility measured using the Timed Up and Go (TUG) test. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Adjustment | Change in psychosocial adjustment scores based on the Hacettepe Psychological Adjustment Scale for Children (parent-rated). | Baseline and Week 6 |
| Treatment Tolerance and Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Özge Baykan Çopuroğlu, Asst. Prof. | Contact | +905544562877 | ozgebaykancopuroglu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kayseri University | Kayseri | Kayseri | 38130 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27188686 | Background | Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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This is a randomized controlled trial with a parallel assignment model. Participants will be randomly allocated into three parallel intervention groups: (1) robot-assisted gait training, (2) hydrotherapy, and (3) conventional physiotherapy. Each group will receive two sessions per week for six weeks. The interventions will be administered independently, with no crossover between groups. Outcome measures will be assessed at baseline and after the six-week intervention period.
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No masking will be implemented in this study. All participants, care providers, investigators, and outcome assessors will be aware of the assigned interventions due to the nature of the treatment protocols.
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| Hydrotherapy | Behavioral | Participants will engage in supervised aquatic therapy including structured exercises in a therapeutic pool. Each session lasts 40 minutes, twice a week, for 6 weeks. Exercises include water walking, floating resistance training, jumping, and balance activities designed for children with spastic hemiparetic cerebral palsy to improve strength, coordination, and functional mobility. |
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| Conventional Physiotherapy | Behavioral | This intervention includes 20 minutes of faradic electrical stimulation and 20 minutes of therapeutic exercises such as stretching, positioning, range of motion, and gait training. Administered twice a week for 6 weeks. The protocol aims to support neuromuscular activation and improve gait and mobility in children with spastic hemiparetic cerebral palsy. |
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Number of completed sessions out of 12 scheduled sessions during the 6-week intervention period.
| Ongoing through 6 weeks |