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NCT Number: NCT06352762

The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy

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.

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Key information

Conditions

Spastic Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Robotic Rehabilitation Signs and Symptoms Upper Extremity Paresis

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuriye Büyüktaş

Bursa, Nilüfer, 16130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Physiotherapy

Other

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions.

Robotic Rehabilitation

Other

Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. An additional 30 minutes of robotic rehabilitation was applied to the conventional physiotherapy program. Robotic rehabilitation was applied after each session of conventional physiotherapy applications.

Primary outcomes

  1. Muscle Tone

    Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.

    Muscle tone was assessed using the Modified Ashworth Scale. Resistance to passive movement was scored from 0 to 5. Higher scores indicate higher muscle tone. Shoulder extensors, adductors and internal rotators; elbow flexors; forearm pronators, wrist and finger flexors were evaluated. Each region was evaluated individually, and the sum of the measured regions was calculated to determine overall muscle tone.

  2. Upper Extremity Motor Function

    Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.

    The Quality of Upper Extremity Skills Test (QUEST) was used. The test evaluates dexterity and quality of movement. It consists of a total of 7 headings (Independent movements, grasping, weight bearing, protective extension, degree of hand function, degree of spasticity, level of cooperation) and 34 items. Each item is scored between 0-2. A score of 0 indicates that the movement was not achieved, 1 point indicates that it was partially achieved, and 2 points indicates that it was completely achieved. High scores from the test indicate good upper extremity motor functions.

  3. Manual Ability

    Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.

    Abilhand-Kids test was used. This test evaluates children's abilities in daily living activities for the hand and upper extremity. The test consists of 21 items. Each item is scored between 0-2. A score of 0 means that the activity cannot be done, a score of 1 means that the child has difficulty in doing the activity, and a score of 2 means that the activity can be done easily. High scores from the test indicate good manual abilities.

  4. Functional Independence

    Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.

    It was assessed using the pediatric functional independence scale (WeeFIM). It contains a total of 6 topics and 18 questions, including self-control, sphincter control, transfers, locomotion, communication, social and cognitive functions. Each item is scored between 1-7. High scores from the test indicate a high level of independence.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

The Effects of Upper Extremity Robotic Rehabilitation on Upper Extremity Skills and Functional Independence Level in Patients With Spastic Hemiparetic Cerebral Palsy

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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