Cerebral PalsyNCT05115695
The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy
A study testing traditional physiotherapy approach and muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF) in people with Cerebral Palsy and Upper Extremity Dysfunction, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Dysfunction, Upper Extremity Functions
- What is being tested?
- traditional physiotherapy approach and muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46100
About this study
Official title: The Effect of Different Upper Extremity Strengthening Trainings on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy in Kahramanmaras
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.
Read the 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.
- Conditions
- Cerebral Palsy, Upper Extremity Dysfunction, Upper Extremity Functions, Muscle Strength, Cerebral Palsy, Spastic, Cerebral Palsy Spastic Diplegia
- Being tested
- traditional physiotherapy approach, muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)
- Keywords
- Cerebral Palsy, Upper Extremity Dysfunction, Upper Extremity Strengthening, muscle strength, trunk, functionality, Proprioceptive Neuromuscular Facilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physiotherapy approachOther
Also called Neurodevelopmental Therapy (NDT-Bobath)
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.
muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)Other
Also called Proprioceptive Neuromuscular Facilitation (PNF)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: traditional physiotherapy approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: first day of intervention and after the 6 weeks
Hand grip strength
Hand grip strength will be measured with Jamar hand dynamometer.
Measured: first day of intervention and after the 6 weeks
Pinch grip strength
Pinch grasp strength will be measured by Pinch Meter.
Measured: first day of intervention and after the 6 weeks
Secondary outcomes (1)
The change of the Modified Ashworth Scale (MASH)
The Modified Ashworth Scale (MASH) is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination. Spasticity of the bilateral pectoralis, elbow flexors, pronators, wrist and finger flexors muscles in the upper extremity will be evaluated. The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the affected joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension.
Measured: first day of intervention and after the 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Mar 2022
- Primary completion15 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- zekiye ipek katirci kirmaci, PhD, Study chair, Kahramanmaras Sutcu Imam Universitymehmet göğremiş, PhD, Study chair, Kahramanmaras Sutcu Imam UniversityDeniz Tuncel Berktas, Proffessor, Study chair, Kahramanmaras Sutcu Imam UniversityCengiz Dilber, Proffessor, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115695
- Sponsor's protocol ID
- hatice
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Upper Extremity Strengthening Trainings on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy in Kahramanmaras
- ClinicalTrials.gov ID
- NCT05115695
- Acronym / sponsor ID
- hatice
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PNF/Interventional | Active comparator | Other: muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)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. |
| NDT/Experimental | Experimental | Other: traditional physiotherapy approachUpper 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional physiotherapy approachAlso: Neurodevelopmental Therapy (NDT-Bobath)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. | Other | NDT/Experimental |
| muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF)Also: Proprioceptive Neuromuscular Facilitation (PNF)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. | Other | PNF/Interventional |
Primary outcome
The change of Manual Ability Classification System (MACS)
Time frame: first day of intervention and after the 6 weeks
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.
The change of the Abilhand Kids Scale
Time frame: first day of intervention and after the 6 weeks
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.
The change of the Jebsen-Taylor Hand Function Test (JEFT)
Time frame: first day of intervention and after the 6 weeks
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.
The change of the 9-hole Peg test (9DPT)
Time frame: first day of intervention and after the 6 weeks
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.
The change of the Purdue-Peg board test
Time frame: first day of intervention and after the 6 weeks
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.
The change of the strength of upper extremity muscle
Time frame: first day of intervention and after the 6 weeks
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)).
The change of the Trunk Control Measurement Scale (TCMS)
Time frame: first day of intervention and after the 6 weeks
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.
Hand grip strength
Time frame: first day of intervention and after the 6 weeks
Hand grip strength will be measured with Jamar hand dynamometer.
Pinch grip strength
Time frame: first day of intervention and after the 6 weeks
Pinch grasp strength will be measured by Pinch Meter.
1 secondary outcome
The change of the Modified Ashworth Scale (MASH)
Time frame: first day of intervention and after the 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zekiye ipek katirci kirmaci, PhD study chair
Kahramanmaras Sutcu Imam University
mehmet göğremiş, PhD study chair
Kahramanmaras Sutcu Imam University
Deniz Tuncel Berktas, Proffessor study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional physiotherapy approach and muscle strengthening exercise/Proprioceptive Neuromuscular Facilitation (PNF) in people with Cerebral Palsy and Upper Extremity Dysfunction, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Manual Ability Classification System (MACS) (time frame: first day of intervention and after the 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.