The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy

NCT05115695 | Completed

• 1 other identifier: hatice
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• The change of Manual Ability Classification System (MACS)

  Manual Ability Classification System will be used in hand skills for the evaluation of upper extremity. MACS is a system that classifies children's ability to handle objects during their daily activities. While MACS evaluates the participation of both hands in activities together, it does not evaluate the hands separately.

  first day of intervention and after the 6 weeks

• The change of the Abilhand Kids Scale

  The Abilhand Kids scale is the Abilhands Kids questionnaire, a parent questionnaire that describes the child's ease or difficulty in performing bilateral activities for the assessment of upper extremity skills. 21 items; relates to activities of daily living, such as taking off a T-shirt, filling a glass of water, or putting on a backpack. Scoring items; recorded as impossible, difficult, or easy. After the survey is completed, it is scored regardless of how the items are completed. A maximum total of 42 points is obtained. Scores are '0 = Impossible', '1 = Difficult' and '2 = Easy'. A maximum of 42 points can be obtained. Higher score indicates better score.

  first day of intervention and after the 6 weeks

• The change of the Jebsen-Taylor Hand Function Test (JEFT)

  The Jebsen-Taylor Hand Function Test (JEFT) consists of a series of subtests representing hand functions in daily life for the evaluation of hand functions. Separate tests are performed for the dominant and non-dominant extremities, and the time to perform five tests for each hand is recorded in seconds. Apart from the sub-parameter of writing, a total of 6 functions, including turning the page, throwing small objects into the box, warning to eat, lining up the checkerboards, lifting large-light objects and lifting large-heavy objects, are standardized and implemented.

  first day of intervention and after the 6 weeks

• The change of the 9-hole Peg test (9DPT)

  The 9-hole Peg test (9DPT) is one of the most commonly used tools to assess dexterity. It is an upper extremity skill test that can be completed in a short time. Tests can be done on both hands. Test materials consist of nine holes on a flat, small test battery and nine wooden sticks that fit into them. The subjects are asked to take the rods one by one from the chamber at the top of the test battery and place them in the holes at the bottom of the chamber without any order, then take the rods out of the holes and put them in the upper chamber. Time taken to complete the test, sec. recorded in . The test is reliable and valid.

  first day of intervention and after the 6 weeks

• The change of the Purdue-Peg board test

  The Purdue-Peg board test (PPBT) is one of the most commonly used tests for selecting personnel for jobs that require motor skills and coordination. It is a test that also measures fingertip dexterity required in assembly works. Washers, rings and small nails are used in this test. The test completion time is recorded in seconds. The test is valid and reliable.

  first day of intervention and after the 6 weeks

• The change of the strength of upper extremity muscle

  Strength of bilateral pectorals, rhomboids, serratus anterior, trapezius, deltoid, supraspinatus, infraspinatus, teres minor, biceps brachy, wrist extensors and flexors with digital muscle strength measurement device ((Commander Echo Base Kit+Echo Muscle Tester (J-Tech)).

  first day of intervention and after the 6 weeks

• The change of the Trunk Control Measurement Scale (TCMS)

  The Trunk Control Measurement Scale (TCMS) consists of two main parts: static sitting balance and dynamic sitting balance. Static sitting balance examines static trunk control during movements of the upper and lower extremities. Dynamic control of sitting; It is divided into two as selective motor control and dynamic reach. Selective control of dynamic sitting balance is a scale that evaluates certain movements of the trunk in three planes (flexion, extension, lateral flexion and rotation). Total score ranges between 0 and 58 and higher scores reflect better control.

  first day of intervention and after the 6 weeks

• Hand grip strength

  Hand grip strength will be measured with Jamar hand dynamometer.

  first day of intervention and after the 6 weeks

• Pinch grip strength

  Pinch grasp strength will be measured by Pinch Meter.

  first day of intervention and after the 6 weeks

Secondary Outcomes (1)

• The change of the Modified Ashworth Scale (MASH)

  first day of intervention and after the 6 weeks

Study Arms (2)

PNF/Interventional

ACTIVE COMPARATOR

Upper extremity and scapular patern of PNF exercise approach will be applied to the first group for 6 weeks, 3 days a week, 30 minutes a day.

Other: muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)

NDT/Experimental

EXPERIMENTAL

Upper extremity strengthening exercises consisting of Neurodevelopmental Therapy (NGT-Bobath) approaches will be applied to the second group for 45 minutes, 3 days a week for 6 weeks.

Other: traditional physiotherapy approach

Interventions

traditional physiotherapy approach OTHER

Traditional upper extremity strengthening and tonus regulation (weight shifting, weight bearing, active reaching in sitting exercises) exercises consisting of Neurodevelopmental Therapy (NDT-Bobath) approaches will be applied to the second group for 45 minutes, 3 days a week for 6 weeks.

Also known as: Neurodevelopmental Therapy (NDT-Bobath)

NDT/Experimental

muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF) OTHER

Muscle strengthening with scapular and upper extremity patterns of PNF exercise approach will be applied to the first group for 6 weeks, 3 days a week, 30 minutes a day.

Also known as: Proprioceptive Neuromuscular Facilitation (PNF)

PNF/Interventional

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• zekiye ipek katirci kirmaci, PhD

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

• mehmet göğremiş, PhD

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

• Deniz Tuncel Berktas, Proffessor

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

• Cengiz Dilber, Proffessor

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluations will be made twice, before and after the treatment. All assessments will be made by a different physician physiotherapist who is unfamiliar with the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 10, 2021
• Study Start: March 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)