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

NCT06352762 | Completed

• 1 other identifier: Izmir Dokuz Eylul University
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Hemiplegic Cerebral Palsy; Upper Extremity Paresis; Robotic Rehabilitation

Keywords

Spastisity; Motor Function; Cerebral Palsy; Upper Extremity

Outcome Measures

Primary Outcomes (4)

• Muscle Tone

  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.

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

• Upper Extremity Motor Function

  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.

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

• Manual Ability

  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.

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

• Functional Independence

  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.

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

Study Arms (2)

Conventional physiotherapy

ACTIVE COMPARATOR

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.

Other: Conventional physiotherapy

Robotic Rehabilitation

EXPERIMENTAL

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. In addition, upper extremity robotic rehabilitation was applied.

Other: Robotic Rehabilitation

Interventions

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.

Conventional physiotherapy

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.

Robotic Rehabilitation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Nuriye Büyüktaş

Bursa, Nilüfer, 16130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Paresis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Nuriye Büyüktaş, MsC

  Izmir Bakircay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effects of Upper Extremity Robotic Rehabilitation in Children with Spastic Hemiparetic Cerebral Palsy

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 8, 2024
• Study Start: February 15, 2017
• Primary Completion: August 15, 2017
• Study Completion: December 15, 2017
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)