Clinical trial NCT05115695: The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy
Official title: The Effect of Different Upper Extremity Strengthening Trainings on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy in Kahramanmaras
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Upper Extremity Dysfunction
Upper Extremity Functions
Muscle Strength
Cerebral Palsy, Spastic
Cerebral Palsy Spastic Diplegia
Keywords: Cerebral Palsy
Upper Extremity Dysfunction
Upper Extremity Strengthening
muscle strength
trunk
functionality
Proprioceptive Neuromuscular Facilitation
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include 30 children with cerebral palsy (CP) diagnosed at the GMFCS I-II level with 15 controls and 15 treatment groups. Included individuals (n=30) will be randomized by simple random method and divided into 2 groups. 2 groups; different upper extremity strengthening training and 1 grup (n=15,control): Neurodevelopmental Treatment (NDT-Bobath) approaches will be applied to the second group for 6 weeks, 3 days a week, 45 minutes a day. Group 2: An exercise approach with Proprioceptive Neuromuscular Facilitation (PNF) (n=15, exercise group) UE patterns will be applied to the first group for 30 minutes, 3 days a week for 6 weeks.
Primary purpose: TREATMENT

Brief summary: Cerebral Palsy (CP) is an activity limitation, movement and posture deficiencies in early stage of life. In 80% of these children, upper extremity (UE) dysfunctions are observed, which leads to loss of quality of life, resulting in limited participation in activities of daily living (ADL). When the hands are affected in UE, fine motor skills such as grasping, writing and object manipulation are usually limited. This results in inadequate use of the extremities in functional activities. Although all children with CP are known to be affected by UE, studies in terms of physiotherapy and rehabilitation methods mostly focused on children with hemiparetic CP. Similar problems are observed in children with bilateral involvement. However, a wide variation is observed in the bimanual performance of children with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with CP; emphasized that the inability to manipulate objects manually is one of the most important reasons for the restriction of participation in ADLs. Physiotherapy and rehabilitation programs include many neurodevelopmental treatment approaches including stretching, strengthening, positioning, splinting, casting, orthosis selection and movement facilitation. However, it is known that studies investigating the current efficacy of these treatments on UE functions mostly focus on unilateral CP. Interventions that focus on improving UE functions in children with bilateral CP are limited. In UE rehabilitation in bilateral CP; states that target-focused therapy, bimanual intensive task specific training programs and trainings such as HABIT (intensive bimanual training of the upper extremity) involving the lower extremity have been used, but there is only evidence for HABIT-ILE (HABIT involving the lower extremity). In the literature, it is observed that strengthening training with the Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in these children. In this study, in the UE rehabilitation of children with hemiparetic and diparetic CP; in order to stimulate motor responses and improve neuromuscular control and function, the superiority of the PNF approach applied with scapular and UE patterns over the traditional Neurodevelopmental Therapy (NGT-Bobath) method will be determined.

Detailed description: European SP Surveillance (SCPE), CP subtypes according to the dominant type of tone and movement abnormality; divided into spastic, dyskinetic and ataxic CP. Spastic type SP; unilateral spastic (hemiparetic) and bilateral (quadriparetic and diparetic), dyskinetic SP; defined as dystonic and choreoathetotic. Spastic type constitutes 90% of this population and bilateral/unilateral involvement is observed in this group. In 80% of these children, upper extremity (UE) dysfunctions are observed, which leads to loss of quality of life, resulting in limited participation in activities of daily living (ADL).Children with CP as a result of damage to the motor cortex and corticospinal tracts; develop abnormal movement patterns by having difficulties in reaching, grasping and fine motor skills of UE. When the hands are affected in UE, fine motor skills such as grasping, writing and object manipulation are usually limited. This results in inadequate use of the extremities in functional activities. Although all children with CP are known to be affected by UE, studies in terms of physiotherapy and rehabilitation methods mostly focused on children with hemiparetic CP. The most common in children with hemiparetic CP; increase in muscle tone and decreased normal joint movement (ROM), decrease in UE muscle and grip strength, primitive grasping reflex, loss of speed and dexterity are observed. In addition to pure motor impairment, sensorimotor problems are also observed. Similar problems are observed in children with bilateral involvement. However, a wide variation is observed in the bimanual performance of children with hemiparetic and bilateral involvement. Studies evaluating UE activities in children with CP; emphasized that the inability to manipulate objects manually is one of the most important reasons for the restriction of participation in ADLs. In a study examining UE disorders, hand dexterity, grip strength and functionality in ADLs in children with diparetic CP; it was emphasized that these children also had deficiencies in dexterity, grip strength and functions in ADL. Therefore, it has been shown that these children are also negatively affected in terms of hand skills, coordination, UE muscle strength, grip strength, ADL and functional skills compared to their healthy peers. Observing that UE rehabilitation in CP remains in the background, studies on the pathophysiology and treatment of UE sequelae in the last 5 years have come to the fore. Physiotherapy and rehabilitation programs; it includes many neurodevelopmental treatment approaches including stretching, strengthening, positioning, splinting, casting, orthosis selection and movement facilitation. However, it is known that studies investigating the current efficacy of these treatments on UE functions mostly focus on unilateral CP. Interventions that focus on improving UE functions in children with bilateral CP are limited. In UE rehabilitation in bilateral CP; states that target-focused therapy, bimanual intensive task specific training programs and trainings such as HABIT (intensive bimanual training of the upper extremity) involving the lower extremity have been used, but there is only evidence for HABIT-ILE (HABIT involving the lower extremity). In the literature, it is observed that strengthening training with the Proprioceptive Neuromuscular Facilitation (PNF) method, which makes a significant contribution to muscle strength balance, is mostly used in lower extremity rehabilitation in CP. In this study, in the UE rehabilitation of children with hemiparetic and diparetic CP; in order to stimulate motor responses and improve neuromuscular control and function, the superiority of the PNF approach applied with scapular and UE patterns over the traditional Neurodevelopmental Therapy (NGT-Bobath) method will be determined. As a result of this study, it is thought that in addition to traditional NGT-Bobath treatment approaches, muscle strengthening with scapular pattern and upper extremity patterns of PNF can be an effective treatment alternative in the UE rehabilitation of children with CP, and it is thought that UE functional skills, muscle strength and trunk control of individuals will be positively affected. Included children will be randomized by simple randomisation and divided into 2 groups. An exercise approach with PNF UE patterns will be applied to the first group for 30 minutes, 3 days a week for 6 weeks. UE rehabilitation consisting of Neurodevelopmental Treatment (NGT-Bobath) approaches will be applied to the second group for 6 weeks, 3 days a week, 45 minutes a day. Treatments will be carried out by the same doctor physiotherapist investigator. Evaluations will be made twice, before and after the treatment. All assessments will be made by a blind doctor physiotherapist investigator who is unfamiliar with the treatment groups. Alongside the studies in the literature, this study will be the first to compare the effectiveness of the use of UE patterns of PNF in children with hemiparetic and diparetic CP.

Eligibility criteria: Inclusion Criteria:

1. Having been diagnosed with CP according to SCPE criteria
2. Be between 8-18 years old
3. Volunteering to participate in the study
4. Hand functions 1-2 according to MACS
5. To be at the level of 1-2-3 according to the GMFCS (Gross Motor Function Classification System)
6. Individuals with hemiparetic-diparetic CP who can take verbal commands
7. Upper extremity muscle tone ≤ 2 according to Modified Ashworth Scale (MASH)

Exclusion Criteria:

1. Less than 8 years old, over 18 years old
2. Receiving any UE surgery / Botulinum toxin (Btx) treatment in the last 6 months
3. Having other known neurological disease
4. Any upper extremity contracture

Primary outcomes:
measure: The change of Manual Ability Classification System (MACS)
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the Abilhand Kids Scale
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the Jebsen-Taylor Hand Function Test (JEFT)
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the 9-hole Peg test (9DPT)
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the Purdue-Peg board test
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the strength of upper extremity muscle
timeFrame: first day of intervention and after the 6 weeks
measure: The change of the Trunk Control Measurement Scale (TCMS)
timeFrame: first day of intervention and after the 6 weeks
measure: Hand grip strength
timeFrame: first day of intervention and after the 6 weeks
measure: Pinch grip strength
timeFrame: first day of intervention and after the 6 weeks
Secondary outcomes:
measure: The change of the Modified Ashworth Scale (MASH)
timeFrame: first day of intervention and after the 6 weeks
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: zekiye ipek katirci kirmaci, PhD
role: STUDY_CHAIR
affiliation: Kahramanmaras Sutcu Imam University
name: mehmet göğremiş, PhD
role: STUDY_CHAIR
affiliation: Kahramanmaras Sutcu Imam University
name: Deniz Tuncel Berktas, Proffessor
role: STUDY_CHAIR
affiliation: Kahramanmaras Sutcu Imam University
name: Cengiz Dilber, Proffessor
role: STUDY_CHAIR
References: