Clinical trial NCT06352762: The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy
Official title: The Effects of Upper Extremity Robotic Rehabilitation on Upper Extremity Skills and Functional Independence Level in Patients With Spastic Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Upper Extremity Paresis
Robotic Rehabilitation
Keywords: Spastisity
Motor Function
Cerebral Palsy
Upper Extremity
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way.
Primary purpose: TREATMENT

Brief summary: Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).

Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level.

Detailed description: Cerebral Palsy (CP) is a permanent but non-progressive neurodevelopmental disorder that occurs in the immature brain and causes activity limitations in children. Epilepsy, cognitive disorders, behavioral disorders, visual-hearing losses and sensory disorders may be observed in children with CP along with motor damage. Motor dysfunction disorders constitute one of the most basic problems in patients with CP. Hand-arm coordination disorders, grip disorders and sensory disorders in the upper extremities negatively affect the daily life activities and functional independence levels of patients. It has been shown that neglect occurs with advancing age in cases with CP when upper limb treatment is delayed, and compensation mechanisms develop involving the use of unaffected side upper limbs to ensure daily living activities. Upper limb functional skills are very important to be able to perform daily life activities. It is not possible to perform activities such as holding and releasing objects, reaching for objects with non-functional upper limbs. Abnormal posture and deformities caused by spasticity restrict the functions of the upper extremities, make daily living activities difficult and increase the burden of people caring for the child. With the technological developments in recent years, virtual reality applications and robotic rehabilitation programs play an important role in CP rehabilitation. Significant improvements have been shown, especially in the development of walking, balance and postural control. Intensive practical, frequent repetitive movements and functional activities can be provided simultaneously in the same session with robotic rehabilitation applications. In the literature, the effects of robotic rehabilitation applications have been investigated in adult neurological patients. In pediatric patients, studies generally focus on lower limb function and walking. The number of studies examining the effect of robotic rehabilitation on upper limb functions in children with CP are limited. Based on these deficiencies in the literature, the purpose of the planned study was to examine the effect of upper limb robotic rehabilitation on upper limb functions and functional independence level in children diagnosed with spastic hemiparetic CP.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with spastic hemiparetic CP
* Upper extremity muscle tone between 1-3 according to the Modified Ashworth Scale
* According to Gross Motor Functional Clasification System level 1-2-3
* Able to understand simple instructions

Exclusion Criteria:

* Having a history of epilepsy
* Having botox in the last 6 months
* Having surgery in the last 6 months

Primary outcomes:
measure: Muscle Tone
timeFrame: Assessment was performed twice, before treatment started and at the end of the fifth week.
measure: Upper Extremity Motor Function
timeFrame: Assessment was performed twice, before treatment started and at the end of the fifth week.
measure: Manual Ability
timeFrame: Assessment was performed twice, before treatment started and at the end of the fifth week.
measure: Functional Independence
timeFrame: Assessment was performed twice, before treatment started and at the end of the fifth week.
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nuriye Büyüktaş
state: Nilüfer
Study officials:
affiliation: Izmir Bakircay University
name: Nuriye Büyüktaş, MsC
role: PRINCIPAL_INVESTIGATOR
References: