Cervical RadiculopathyCRNCT06169618
The Relationship Between Cervical Radiculopathy and Eye-hand Coordination
An observational study of Cervical Radiculopathy, run by Cairo University.
Trial summary
this study will be conducted to investigate if there is a relationship between cervical radiculopathy and eye-hand coordination. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- cervical radiculopathy and normal group
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Jan 2024
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: the first population will be thirty with cervical radiculopathy, the second group will be thirty subjects with the normal state
Who may be able to join
- Subjects normal with no neck complain.
- Patients of cervical radiculopathy due to cervical discogenic lesion.
- Ages range from 30-50 both males and females.
- Subjects should be able to follow simple verbal commands or instructions included in the procedures.
Who cannot join
- Participants with any neck trauma.
- Cervical Post-operative patients.
- Participants with vision deficiency.
- Participants with perceptual and cognitive problems with score less than 24 in mini mental state scale (Appendix I) (Goudsmit et al., 2018).
- Participants with any other neurological or musculoskeletal problems.
- Participants take medications that affect their attention.
- Participants have space-occupying lesions eg. tumors
About this study
this study will be conducted to investigate if there is a relationship between cervical radiculopathy and eye-hand coordination.
Read the detailed description
Cervical radiculopathy is a disorder involving dysfunction of the cervical nerve roots commonly secondary to cervical spine degenerative changes such as disk herniation and/or foraminal stenosis compressing the nerve roots. Clinical manifestations are pain in neck and one or both of the upper extremities, as a result of compression or irritation of nerve roots in the cervical spine. It can be accompanied by motor, sensory, or reflex deficits. It is most common in persons 45-60 years of age, which result in terrible chronic pain. Eye hand coordination is the ability to do activities which require the simultaneous use of hands and eyes. It is a complex cognitive skill which unites visual and motor skills in the person and allowing the hands to guide by the visual stimulations. It lies at the core of our daily activities and interactions with objects and people around us as to be a defining characteristic of typical human life. Previous studies show that there was a marked alteration in the hand function in subjects with the cervical radiating pain. Since there was no study which investigated the relationship between cervical radiculopathy and eye hand coordination despite it is an important skill that adults use in countless activities of daily living and during working.
- Conditions
- Cervical Radiculopathy
- Being tested
- cervical radiculopathy, normal group
- Keywords
- eye hand co ordination, cervical radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical radiculopathyOther
this group will have patients with cervical radiculopathy
normal groupOther
this group will have normal subjects
| Study group | Role | What they receive |
|---|---|---|
| cervical radiculopathy group | thirty participants with cervical radiculopathy due to discogenic lesions. Receives: Other: cervical radiculopathy | |
| normal group | thirty participants in normal without any discogenic lesion Receives: Other: normal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye hand coordination movement speed objectively
The Purdue Pegboard test will be used to assess eye hand coordination speed by putting as many pins as possible into the pegboard in 30 sec. the Test will be done three times each and averaged. The score for each of the four subtests
Measured: baseline
pain intensity
numerical pain rating scale will be used for assessment of pain intensity. It is a single 11-point numeric scale. The physical therapist will ask the patient to state a number from 1 to 10 that best represents their perceived current pain intensity or pain intensity "in the last 24 hours". Zero usually represents 'no pain at all' whereas 10 is the upper limit represents 'the worst pain ever possible'
Measured: baseline
eye hand coordination accuracy and timing
talking pen test will used to assess the accuracy and timing; Patient will grasp the pen like any writing tool with the thumb, index finger and middle finger. Patient will hold the pen at no less than a 45 angle from the writing space. An infra-red light and fiber optic sensor in the tip of the pen sense reflect as the user traces a pattern with the pen and provide immediate auditory feedback if the user wanders off the pattern.
Measured: baseline
eye hand coordination movement speed subjectively
wall catch test will be used to assess eye hand coordination movement speed;A bucket of tennis balls will be available directly in front of the participant and a ball will be held in the dominant hand. The physical therapist will count down '3, 2, 1, go' and start the stopwatch, the ball will be thrown underarm off the wall and the return will be caught in their opposing hand. The participant then continue to throw and catch the ball in alternative hands for 30 s. If a ball is dropped, participants will be instructed to reach into the bucket of balls and to continue the test as quickly as possible.
Measured: baseline
eye hand coordination upper and limb muscles coordination
standardized finger to nose test will be used to assess eye hand coordination upper and limb muscles coordination; Test will be performed with patient starting position then the patient will be asked to bring the tip of index finger to the tip of his nose then to touch a target 45 cm at arm's length and return to touch their nose again. It consists of recording how many times the individuals alternately touched their tip of their nose and a target placed in front of them on a wall
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Saeed Ibrahim el Gabry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169618
- Sponsor's protocol ID
- P.T.REC/012/004095
- Acronym
- CR
- Status last verified
- Dec 2023
- First submitted
- 5 Nov 2023
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Cervical Radiculopathy and Eye-hand Coordination
- ClinicalTrials.gov ID
- NCT06169618
- Acronym / sponsor ID
- CR / P.T.REC/012/004095
- Conditions
- Cervical Radiculopathy
- Keywords
- eye hand co ordination, cervical radiculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 13 Dec 2023 (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.
this study will be conducted to investigate if there is a relationship between cervical radiculopathy and eye-hand coordination.
Detailed description
Cervical radiculopathy is a disorder involving dysfunction of the cervical nerve roots commonly secondary to cervical spine degenerative changes such as disk herniation and/or foraminal stenosis compressing the nerve roots. Clinical manifestations are pain in neck and one or both of the upper extremities, as a result of compression or irritation of nerve roots in the cervical spine. It can be accompanied by motor, sensory, or reflex deficits. It is most common in persons 45-60 years of age, which result in terrible chronic pain. Eye hand coordination is the ability to do activities which require the simultaneous use of hands and eyes. It is a complex cognitive skill which unites visual and motor skills in the person and allowing the hands to guide by the visual stimulations. It lies at the core of our daily activities and interactions with objects and people around us as to be a defining characteristic of typical human life. Previous studies show that there was a marked alteration in the hand function in subjects with the cervical radiating pain. Since there was no study which investigated the relationship between cervical radiculopathy and eye hand coordination despite it is an important skill that adults use in countless activities of daily living and during working.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical radiculopathy group | – | Other: cervical radiculopathythirty participants with cervical radiculopathy due to discogenic lesions. |
| normal group | – | Other: normal groupthirty participants in normal without any discogenic lesion |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the first population will be thirty with cervical radiculopathy, the second group will be thirty subjects with the normal state
Key inclusion criteria (4 listed)
- Subjects normal with no neck complain.
- Patients of cervical radiculopathy due to cervical discogenic lesion.
- Ages range from 30-50 both males and females.
- Subjects should be able to follow simple verbal commands or instructions included in the procedures.
Key exclusion criteria (7 listed)
- Participants with any neck trauma.
- Cervical Post-operative patients.
- Participants with vision deficiency.
- Participants with perceptual and cognitive problems with score less than 24 in mini mental state scale (Appendix I) (Goudsmit et al., 2018).
- Participants with any other neurological or musculoskeletal problems.
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 |
|---|---|---|
| cervical radiculopathythis group will have patients with cervical radiculopathy | Other | cervical radiculopathy group |
| normal groupthis group will have normal subjects | Other | normal group |
Primary outcome
eye hand coordination movement speed objectively
Time frame: baseline
The Purdue Pegboard test will be used to assess eye hand coordination speed by putting as many pins as possible into the pegboard in 30 sec. the Test will be done three times each and averaged. The score for each of the four subtests
pain intensity
Time frame: baseline
numerical pain rating scale will be used for assessment of pain intensity. It is a single 11-point numeric scale. The physical therapist will ask the patient to state a number from 1 to 10 that best represents their perceived current pain intensity or pain intensity "in the last 24 hours". Zero usually represents 'no pain at all' whereas 10 is the upper limit represents 'the worst pain ever possible'
eye hand coordination accuracy and timing
Time frame: baseline
talking pen test will used to assess the accuracy and timing; Patient will grasp the pen like any writing tool with the thumb, index finger and middle finger. Patient will hold the pen at no less than a 45 angle from the writing space. An infra-red light and fiber optic sensor in the tip of the pen sense reflect as the user traces a pattern with the pen and provide immediate auditory feedback if the user wanders off the pattern.
eye hand coordination movement speed subjectively
Time frame: baseline
wall catch test will be used to assess eye hand coordination movement speed;A bucket of tennis balls will be available directly in front of the participant and a ball will be held in the dominant hand. The physical therapist will count down '3, 2, 1, go' and start the stopwatch, the ball will be thrown underarm off the wall and the return will be caught in their opposing hand. The participant then continue to throw and catch the ball in alternative hands for 30 s. If a ball is dropped, participants will be instructed to reach into the bucket of balls and to continue the test as quickly as possible.
eye hand coordination upper and limb muscles coordination
Time frame: baseline
standardized finger to nose test will be used to assess eye hand coordination upper and limb muscles coordination; Test will be performed with patient starting position then the patient will be asked to bring the tip of index finger to the tip of his nose then to touch a target 45 cm at arm's length and return to touch their nose again. It consists of recording how many times the individuals alternately touched their tip of their nose and a target placed in front of them on a wall
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Radiculopathy, run by Cairo University.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
eye hand coordination movement speed objectively (time frame: baseline). The study lists 5 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 13 Dec 2023.