Cerebral PalsyNCT05013814
The Effect of Tactile Deficit on Motor Function in Unilateral Cerebral Palsy
An observational study of Cerebral Palsy and Rehabilitation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy(CP) is the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Rehabilitation, Tactile Perception
- What is being tested?
- Semmes-Weinstein monofilament test, Box and Block Test and 9-Hole Peg Test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 Jan 2020
- Phase
- Observational
- 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 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of 2 groups. In the group of typically developed children, there are healthy children who do not have a disease that will affect normal development. The other group includes children diagnosed with unilateral cerebral palsy.
Who may be able to join
- Ages between 5-15 years
- Being evaluated as Class I-II-III in Gross Motor Function Classification System
- Being evaluated as Class I-II-III in Manual Ability Classification System
Who cannot join
- Inability to understand and/or follow test instructions due to intellectual or behavioral difficulties
- History of upper extremity botulinum toxin type A injection in the last three months,
- Previous upper extremity orthopedic surgery
- History of major trauma, and visual impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Education and Research Hospital
Istanbul, 34899
About this study
Official title: Comparison of the Tactile Functions and the Effects of Possible Tactile Deficit on Motor Function in Unilateral Cerebral Palsy and the Typically Developed Children
Cerebral palsy(CP) is the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Besides classical appearance of symptomatology, tactile impairment takes an important place to be evaluated. Assessment of the integrity of tactile function composes of two main steps: tactile registration and tactile perception. Our main goal is the define the effect of tactile impairment on hand motor function with the usage of identical assessment tools in patients with unilateral cerebral palsy (UCP) and typically developed children (TDC).
- Conditions
- Cerebral Palsy, Rehabilitation, Tactile Perception
- Being tested
- Semmes-Weinstein monofilament test, Box and Block Test, 9-Hole Peg Test, Duruöz Hand Index (DHI), Jamar hand dynamometer
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semmes-Weinstein monofilament testDiagnostic test
Tactile function was evaluated mainly as tactile registration by using 20-item Semmes-Weinstein monofilament (SWM) kit. The monofilament was applied three times with a pseudorandom order to distal pad of the thumb, index, 4th and 5th digits (C6, C7 and C8 dermatomes). The lowest value of monofilament was recorded which the child was able to correctly identify at least one touch out of three
Box and Block TestDiagnostic test
Box and Block Test (BBT) was used for dexterity assessment. The BBT measures unilateral gross manual dexterity. The child was asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds
9-Hole Peg TestDiagnostic test
9-Hole Peg Test (9-HPT) is used to measure finger dexterity. Firstly, the child takes the pegs from a container, one by one, and place them in the holes on the board; then participant removes the pegs from the holes and replaces them back into the container. The total time taken to complete the test is recorded in seconds.
Duruöz Hand Index (DHI)Diagnostic test
Duruöz Hand Index (DHI) is an 18-item self-report questionnaire regarding ability to carry out manual tasks. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The total score ranges from 0-90 with higher scores indicating poorer hand function.
Jamar hand dynamometerDiagnostic test
Hand grip strength was measured by using Jamar hydraulic hand dynamometer. Measurement was done with the participant in sitting position and the elbow at 90 degrees of flexion. The force has most commonly been measured in kilograms according to the amount of static force that the hand can squeeze around the dynamometer.
Hydraulic pinch gaugeDiagnostic test
Hydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Children with unilateral cerebral palsy | Not described Receives: Diagnostic Test: Semmes-Weinstein monofilament test; Diagnostic Test: Box and Block Test; Diagnostic Test: 9-Hole Peg Test; Diagnostic Test: Duruöz Hand Index (DHI); Diagnostic Test: Jamar hand dynamometer; Diagnostic Test: Hydraulic pinch gauge | |
| Typically developed children | Not described Receives: Diagnostic Test: Semmes-Weinstein monofilament test; Diagnostic Test: Box and Block Test; Diagnostic Test: 9-Hole Peg Test; Diagnostic Test: Duruöz Hand Index (DHI); Diagnostic Test: Jamar hand dynamometer; Diagnostic Test: Hydraulic pinch gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with tactile dysfunction in both groups
Comparison of the number of patients with tactile dysfunction according to the Semmes-Weinstein monofilament test scores.
Measured: 1 day (Single time point)
Mean score of gross manual dexterity assessment test in all participants
Mean score of Box-Block Test was used to compare gross manual dexterity assessment in both groups
Measured: 1 day (Single time point)
Mean score of hand grip strength test in all participants
Mean score of Jamar dynamometer measures was used to compare hand grip strength in both groups
Measured: 1 day (Single time point)
Mean score of hand function test in all participants
Mean score of Duruöz Hand Index was used to compare hand function in both groups
Measured: 1 day (Single time point)
Mean score of finger dexterity assessment test in all participants
Mean score of 9-Hole Peg Test was used to compare finger dexterity assessment in both groups
Measured: 1 day (Single time point)
Mean score of finger grip strength test in all participants
Mean score of pinch gauge measures was used to compare finger grip strength in both groups
Measured: 1 day (Single time point)
Secondary outcomes (5)
Mean score of gross manual dexterity assessment test according to the tactile function
Tactile function was determined by the Semmes-Weinstein monofilament score. The Box-Block Test scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.
Measured: 1 day (Single time point)
Mean score of hand grip strength test according to the tactile function
Tactile function was determined by the Semmes-Weinstein monofilament score. The Jamar dynamometer scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.
Measured: 1 day (Single time point)
Mean score of finger grip strength test according to the tactile function
Tactile function was determined by the Semmes-Weinstein monofilament score. The pinch gauge scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.
Measured: 1 day (Single time point)
Mean score of hand function test according to the tactile function
Tactile function was determined by the Semmes-Weinstein monofilament score. The Duruöz Hand Index scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.
Measured: 1 day (Single time point)
Mean score of finger dexterity assessment test according to the tactile function
Tactile function was determined by the Semmes-Weinstein monofilament score. The 9-Hole Peg Test scores were compared between those with normal and impaired tactile function in the unilateral cerebral palsy group.
Measured: 1 day (Single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Sep 2017
- Primary completion20 Jan 2019
- Study completion1 Jan 2020
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.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag-Saygi, MD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013814
- Sponsor's protocol ID
- 09.2018.312
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Tactile Functions and the Effects of Possible Tactile Deficit on Motor Function in Unilateral Cerebral Palsy and the Typically Developed Children
- ClinicalTrials.gov ID
- NCT05013814
- Acronym / sponsor ID
- 09.2018.312
- Conditions
- Cerebral Palsy, Rehabilitation, Tactile Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Aug 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 the most common cause of disability in childhood. The motor spectrum of disorders is characterized by abnormal muscle tone, posture, and movement. The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition and behavior. Besides classical appearance of symptomatology, tactile impairment takes an important place to be evaluated. Assessment of the integrity of tactile function composes of two main steps: tactile registration and tactile perception. Our main goal is the define the effect of tactile impairment on hand motor function with the usage of identical assessment tools in patients with unilateral cerebral palsy (UCP) and typically developed children (TDC).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with unilateral cerebral palsy | – | Diagnostic Test: Semmes-Weinstein monofilament test, Diagnostic Test: Box and Block Test, Diagnostic Test: 9-Hole Peg Test, Diagnostic Test: Duruöz Hand Index (DHI), Diagnostic Test: Jamar hand dynamometer, Diagnostic Test: Hydraulic pinch gauge |
| Typically developed children | – | Diagnostic Test: Semmes-Weinstein monofilament test, Diagnostic Test: Box and Block Test, Diagnostic Test: 9-Hole Peg Test, Diagnostic Test: Duruöz Hand Index (DHI), Diagnostic Test: Jamar hand dynamometer, Diagnostic Test: Hydraulic pinch gauge |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of 2 groups. In the group of typically developed children, there are healthy children who do not have a disease that will affect normal development. The other group includes children diagnosed with unilateral cerebral palsy.
Key inclusion criteria (3 listed)
- Ages between 5-15 years
- Being evaluated as Class I-II-III in Gross Motor Function Classification System
- Being evaluated as Class I-II-III in Manual Ability Classification System
Key exclusion criteria (4 listed)
- Inability to understand and/or follow test instructions due to intellectual or behavioral difficulties
- History of upper extremity botulinum toxin type A injection in the last three months,
- Previous upper extremity orthopedic surgery
- History of major trauma, and visual impairment
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 |
|---|---|---|
| Semmes-Weinstein monofilament testTactile function was evaluated mainly as tactile registration by using 20-item Semmes-Weinstein monofilament (SWM) kit. The monofilament was applied three times with a pseudorandom order to distal pad of the thumb, index, 4th and 5th digits (C6, C7 and C8 dermatomes). The lowest value of monofilament was recorded which the child was able to correctly identify at least one touch out of three | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
| Box and Block TestBox and Block Test (BBT) was used for dexterity assessment. The BBT measures unilateral gross manual dexterity. The child was asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
| 9-Hole Peg Test9-Hole Peg Test (9-HPT) is used to measure finger dexterity. Firstly, the child takes the pegs from a container, one by one, and place them in the holes on the board; then participant removes the pegs from the holes and replaces them back into the container. The total time taken to complete the test is recorded in seconds. | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
| Duruöz Hand Index (DHI)Duruöz Hand Index (DHI) is an 18-item self-report questionnaire regarding ability to carry out manual tasks. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The total score ranges from 0-90 with higher scores indicating poorer hand function. | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
| Jamar hand dynamometerHand grip strength was measured by using Jamar hydraulic hand dynamometer. Measurement was done with the participant in sitting position and the elbow at 90 degrees of flexion. The force has most commonly been measured in kilograms according to the amount of static force that the hand can squeeze around the dynamometer. | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
| Hydraulic pinch gaugeHydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer. | Diagnostic test | Children with unilateral cerebral palsy, Typically developed children |
Primary outcome
Number of participants with tactile dysfunction in both groups
Time frame: 1 day (Single time point)
Comparison of the number of patients with tactile dysfunction according to the Semmes-Weinstein monofilament test scores.
Mean score of gross manual dexterity assessment test in all participants
Time frame: 1 day (Single time point)
Mean score of Box-Block Test was used to compare gross manual dexterity assessment in both groups
Mean score of hand grip strength test in all participants
Time frame: 1 day (Single time point)
Mean score of Jamar dynamometer measures was used to compare hand grip strength in both groups
Mean score of hand function test in all participants
Time frame: 1 day (Single time point)
Mean score of Duruöz Hand Index was used to compare hand function in both groups
Mean score of finger dexterity assessment test in all participants
Time frame: 1 day (Single time point)
Mean score of 9-Hole Peg Test was used to compare finger dexterity assessment in both groups
Mean score of finger grip strength test in all participants
Time frame: 1 day (Single time point)
Mean score of pinch gauge measures was used to compare finger grip strength in both groups
5 secondary outcomes
Mean score of gross manual dexterity assessment test according to the tactile function
Time frame: 1 day (Single time point)
Mean score of hand grip strength test according to the tactile function
Time frame: 1 day (Single time point)
Mean score of finger grip strength test according to the tactile function
Time frame: 1 day (Single time point)
Mean score of hand function test according to the tactile function
Time frame: 1 day (Single time point)
Mean score of finger dexterity assessment test according to the tactile function
Time frame: 1 day (Single time point)
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 19 Aug 2021.
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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.
Evrim Karadag-Saygi, MD study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Rehabilitation, run by Marmara 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 3 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 19 Aug 2021. 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?
Number of participants with tactile dysfunction in both groups (time frame: 1 day (Single time point)). The study lists 6 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 19 Aug 2021.