Clinical trial NCT05136612: The Effects Of Upper Extremity Robotic Rehabilitation On Upper Extremity Functions And Gait Parameters
Official title: Investigation Of The Effects Of Upper Extremity Robotic Rehabilitation On Upper Extremity Functions And Gait Parameters in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals with CP will be assigned to group 1 or group 2 by simple randomization using the "Research Randomizer" program (https://www.randomizer.org/) prior to treatment.
Primary purpose: TREATMENT

Brief summary: Cerebral Palsy is defined as the cause of movement and posture disorders and activity limitation that develops in the fetal or infant brain that has not yet completed its development. When the literature is examined, although upper extremity and lower extremity involvements are common in individuals with hemiparetic CP, treatment programs are mostly aimed at the lower extremities. However, studies report that the upper extremity is more severely affected than the lower extremities in individuals with hemiparetic CP and that upper extremity functions have an effect on walking. Although different treatment methods have positive effects, their superiority over each other cannot be clearly reported. In this case, new intervention strategies based on sound methodological and scientific foundations are needed. At this point, virtual reality applications and robotic rehabilitation programs have started to play an important role in CP rehabilitation along with current developments in technology-assisted rehabilitation. Robotic devices provide visual, auditory and sensory inputs, making the process fun, while making the individual active in the treatment. It also enables the child to achieve goal-directed movements in children with motor disabilities. Various gait problems are seen in individuals with CP. Therefore, although lower extremity movements during walking have been well analyzed in the literature, upper extremity functions and especially arm movements during walking have received less attention. Although human gait is perceived as a situation that concerns only the lower extremities, it actually includes the coordinated movements of all four extremities. Individuals with hemiplegic CP usually have a markedly deviated arm position and reduced arm movement. This situation also affects the gait and balance of individuals with hemiparetic CP. Individuals change their upper extremity kinematics while increasing their walking speed to optimize gait and increase balance. In the light of this information, practices aimed at improving upper extremity movement and function should be included in the rehabilitation program of patients with hemiparetic CP, considering a holistic approach. Considering all these, we thought that if we increase the functions of the upper extremities, we can improve walking, and we planned this study.

Detailed description: Cerebral Palsy is defined as the cause of movement and posture disorders and activity limitation that develops in the fetal or infant brain that has not yet completed its development. Although CP is the most common physical disorder in childhood, its incidence varies between 1.7-2 people per 1000 live births in developed countries. Although the impairments seen in CP are not progressive, as individuals with CP get older, their current motor function declines dramatically and their independence decreases or disappears as a result. These neurodevelopmental disorders are classified as hemiplegic, diplegic and quadriplegic according to the anatomically affected body parts. Along with motor damage, epilepsy, cognitive disorders, behavioral disorders, visual-hearing losses and sensory disorders can be seen in children with CP. In addition, upper extremity involvement is quite common in individuals with CP. Although upper extremity and lower extremity involvement are common in individuals with hemiparetic CP, treatment programs are mostly aimed at the lower extremities. However, studies report that the upper extremity is more severely affected than the lower extremities in individuals with hemiparetic CP and that upper extremity functions have an effect on walking . Although human gait is perceived as a situation that concerns only the lower extremities, it actually includes the coordinated movements of all four extremities. In a study, it was reported that it is beneficial to encourage arm movements during gait rehabilitation. It has been reported that although individuals with hemiparetic CP gain walking skills, they lag behind their peers in terms of upper extremity functions. This makes upper extremity rehabilitation important. There are various treatment modalities aimed at eliminating upper extremity dysfunction and reducing activity limitations. These; neurodevelopmental treatment approaches, orthoses, forced restrictive movement therapy, virtual reality and robotic rehabilitation applications. Although the different treatment methods have positive effects, their superiority to each other cannot be reported definitively. In this case, new intervention strategies based on sound methodological and scientific foundations are needed.

With the development of technology, the interest in robotic rehabilitation has also increased. The first study examining upper extremity robotic rehabilitation in CP was conducted in 2008. In this study, it was reported that robotic rehabilitation has positive effects on upper extremity motor functions and the use of upper extremities in daily living activities. In a thesis study conducted in our country, conventional physiotherapy and robotic rehabilitation were compared and it was concluded that hand skills improved in both groups, but the increase in the group receiving robotic rehabilitation was statistically significant. In the literature review, it was seen that studies on upper extremity robotic rehabilitation were few and their effects on gait parameters were not examined. In this context, it is thought that in our study, the effects of upper extremity robotic rehabilitation on upper extremity functions and gait parameters will be examined and it will contribute to the literature.

Method: This study was conducted to examine the effects of upper extremity robotic rehabilitation on upper extremity functions and gait parameters in individuals with hemiparetic CP; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 30 individuals with spastic hemiparetic CP, aged between 6-18 years, will be included in our study. The parents of each individual will be informed about the study and will read and sign the consent form stating that they voluntarily participated in the study.

Eligibility criteria: Inclusion Criteria:

* The clinical type is spastic hemiparetic CP.
* Upper extremity spasticity value between 0 and 3 according to Modified Ashworth.
* To have the cognitive level to understand simple instructions.
* It is largely the absence of auditory and visual loss.

Exclusion Criteria:

* not volunteering to participate in the study.

Primary outcomes:
measure: Sociodemographic Data Form
timeFrame: Before starting treatment
measure: Joint Range of Motion (ROM) Measurement
timeFrame: Before starting treatment
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: Before starting treatment
measure: Pediatric Quality of Life Inventory
timeFrame: Before starting treatment
measure: The Jebsen Hand Function Test
timeFrame: Before starting treatment
measure: ABILHAND-Kids
timeFrame: Before starting treatment
measure: The Quality of Upper Extremity Skills Test
timeFrame: Before starting treatment
measure: Selective Control of the Upper Extremity Scale
timeFrame: Before starting treatment
measure: Trunk Control Measurement Scale
timeFrame: Before starting treatment
measure: 4D Diers Formetic
timeFrame: Before starting treatment
measure: Sociodemographic Data Form
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: Joint Range of Motion (ROM) Measurement
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: Pediatric Quality of Life Inventory
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: The Jebsen Hand Function Test
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: ABILHAND-Kids
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: The Quality of Upper Extremity Skills Test
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: Selective Control of the Upper Extremity Scale
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: Trunk Control Measurement Scale
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
measure: 4D Diers Formetic
timeFrame: After 6 weeks of treatment (treatment is 18 sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: bulentelbasan@gmail.com
name: Mustafa BURAK, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Shamy SM. Efficacy of Armeo(R) Robotic Therapy Versus Conventional Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy. Am J Phys Med Rehabil. 2018 Mar;97(3):164-169. doi: 10.1097/PHM.0000000000000852.
citation: Dixit S, Tedla JS. Effectiveness of robotics in improving upper extremity functions among people with neurological dysfunction: a systematic review. Int J Neurosci. 2019 Apr;129(4):369-383. doi: 10.1080/00207454.2018.1536051. Epub 2018 Nov 22.