HemiplegiaNCT05194501
Unaffected Hand in Hemiplegia
An observational study of Hemiplegia and Upper Extremity Problem, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of our study is to evaluate the functional status of the unaffected hand in hemiplegic patients. The secondary aims are to compare the functional states of the unaffected hand between right and left hemiplegias, and to evaluate the relationships between the functional status of the unaffected hand and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia, Upper Extremity Problem
- What is being tested?
- Nine Hole Peg Test, Jamar dynamometer, pinchmeter
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2021to 5 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.
Who may be able to join
- This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group. All patients and healthy volunteers were right hand dominant.
Who cannot join
- Patients with a history of CVA in the last 1 month, bilateral hemispheric ischemic lesion, moderate/severe cognitive impairment, aphasia, neglect, and patients/healthy volunteers with severe systemic, inflammatory, degenerative and neurological diseases that may lead to loss of hand functions, a history of surgery or trauma in the upper extremity in the last 3 months, and younger than 18 years of age were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE FUNCTIONAL STATUS OF THE "UNAFFECTED" HAND IN HEMIPLEGIC PATIENTS
The primary aim of our study is to evaluate the functional status of the unaffected hand in hemiplegic patients. The secondary aims are to compare the functional states of the unaffected hand between right and left hemiplegias, and to evaluate the relationships between the functional status of the unaffected hand and the healing phase of the hemiplegic side and activities of daily living.
This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.
Participants' data on age, gender, height, weight, comorbidities, time after stroke, and affected body half were recorded. In the patient group, the stages for the upper extremity and hand were evaluated according to the Brunnstrom recovery stages. Afterwards, the participants' hand grip strengths were evaluated with a Jamar type hand dynamometer, pinch strengths with a pinchmeter, and hand dexerity with the Nine Hole Peg Test (NHPT). Evaluations were made in the unaffected hand in the patient groups and in both hands in the control group. The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL) and the Functional Independence Measure (FIM) were applied to the patient groups.
- Conditions
- Hemiplegia, Upper Extremity Problem
- Being tested
- Nine Hole Peg Test, Jamar dynamometer, pinchmeter
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nine Hole Peg Test, Jamar dynamometer, pinchmeterOther
Hand grip and pinch strengths: Hand grip strengths and tip pinch strengths were measured using a Jamar type hand dynamometer and pinchmeter available in our clinic.
The Nine Hole Peg Test (NHPT): Hand dexerities were evaluated with the NHPT available in our clinic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip and pinch strengths
Hand grip and pinch strengths: Hand grip strengths and tip pinch strengths were measured using a Jamar type hand dynamometer and pinchmeter available in our clinic. The measurement of hand grip strengths were made with shoulders in adduction and neutral rotation, elbows in 90 degrees flexion, forearms and wrists in neutral position. Tip pinch strengths were measured by squeezing the pinchmeter between the thumb and forefinger [12]. Participants were asked to take a deep breath and grasp with maximal force while exhaling. The measurements were repeated three times with an interval of five minutes, and the average of the values was taken as the basis for the analyses.
Measured: 6 month
The Nine Hole Peg Test (NHPT)
The Nine Hole Peg Test (NHPT): Hand dexerities were evaluated with the NHPT available in our clinic. This test is an assembly consisting of a square platform and storage box. There are nine holes in the square-shaped area and nine cylinders suitable for these holes. The patients are asked to take the 9 cylinders one by one from the storage box as quickly as possible, place them into the holes, and place them back in the storage box one by one after all the cylinders have been placed. Meanwhile, the total time is measured in seconds with the chronometer. Less time indicates better hand dexterity.
Measured: 6 month
The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL)
The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL): Lawton-IADL scale is a scale consisting of eight questions questioning activities use a phone, food preparation, shopping, housekeeping, laundry, use of public transportation, managing self-medication, and handling finances. Each question is scored as 0 (can not perform or can partially perform) or 1 (can perform) [5]. The total score ranges from 0 (low functionality, dependent) to 8 (high functionality, independent). The Turkish validity and reliability study of the scale was conducted by Işık et al. in 2020.
Measured: 6 month
The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM): FIM is an 18-item scale that evaluates the degree of independence of the individual in basic physical and cognitive activities in daily life. It has two main sections in which physical/motor function (13 questions) and cognitive function (5 questions) are evaluated. The part of physical/motor function consists of 4 sub-sections in which different activities [self-care performance (eating, grooming, bathing, upper dressing, lower dressing, toileting), sphincter control, transfers, locomotion] are evaluated. The part of cognitive function consists of 2 sub-sections in which communication and social-cognition are evaluated. Each item is scored from 1 to 7, with 'level 1' representing full assistance and 'level 7' being complete independence. The higher the total score, the higher the level of independence. The Turkish adaptation study of the scale was carried out in 2001 by Küçükdeveci et al.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start5 Mar 2021
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194501
- Sponsor's protocol ID
- 2021-04-04
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE FUNCTIONAL STATUS OF THE "UNAFFECTED" HAND IN HEMIPLEGIC PATIENTS
- ClinicalTrials.gov ID
- NCT05194501
- Acronym / sponsor ID
- 2021-04-04
- Conditions
- Hemiplegia, Upper Extremity Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 18 Jan 2022 (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.
The primary aim of our study is to evaluate the functional status of the unaffected hand in hemiplegic patients. The secondary aims are to compare the functional states of the unaffected hand between right and left hemiplegias, and to evaluate the relationships between the functional status of the unaffected hand and the healing phase of the hemiplegic side and activities of daily living.
This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.
Participants' data on age, gender, height, weight, comorbidities, time after stroke, and affected body half were recorded. In the patient group, the stages for the upper extremity and hand were evaluated according to the Brunnstrom recovery stages. Afterwards, the participants' hand grip strengths were evaluated with a Jamar type hand dynamometer, pinch strengths with a pinchmeter, and hand dexerity with the Nine Hole Peg Test (NHPT). Evaluations were made in the unaffected hand in the patient groups and in both hands in the control group. The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL) and the Functional Independence Measure (FIM) were applied to the patient groups.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.
Key inclusion criteria (1 listed)
- This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group. All patients and healthy volunteers were right hand dominant.
Key exclusion criteria (1 listed)
- Patients with a history of CVA in the last 1 month, bilateral hemispheric ischemic lesion, moderate/severe cognitive impairment, aphasia, neglect, and patients/healthy volunteers with severe systemic, inflammatory, degenerative and neurological diseases that may lead to loss of hand functions, a history of surgery or trauma in the upper extremity in the last 3 months, and younger than 18 years of age were excluded.
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 |
|---|---|---|
| Nine Hole Peg Test, Jamar dynamometer, pinchmeterHand grip and pinch strengths: Hand grip strengths and tip pinch strengths were measured using a Jamar type hand dynamometer and pinchmeter available in our clinic. The Nine Hole Peg Test (NHPT): Hand dexerities were evaluated with the NHPT available in our clinic. | Other | – |
Primary outcome
Hand grip and pinch strengths
Time frame: 6 month
Hand grip and pinch strengths: Hand grip strengths and tip pinch strengths were measured using a Jamar type hand dynamometer and pinchmeter available in our clinic. The measurement of hand grip strengths were made with shoulders in adduction and neutral rotation, elbows in 90 degrees flexion, forearms and wrists in neutral position. Tip pinch strengths were measured by squeezing the pinchmeter between the thumb and forefinger [12]. Participants were asked to take a deep breath and grasp with maximal force while exhaling. The measurements were repeated three times with an interval of five minutes, and the average of the values was taken as the basis for the analyses.
The Nine Hole Peg Test (NHPT)
Time frame: 6 month
The Nine Hole Peg Test (NHPT): Hand dexerities were evaluated with the NHPT available in our clinic. This test is an assembly consisting of a square platform and storage box. There are nine holes in the square-shaped area and nine cylinders suitable for these holes. The patients are asked to take the 9 cylinders one by one from the storage box as quickly as possible, place them into the holes, and place them back in the storage box one by one after all the cylinders have been placed. Meanwhile, the total time is measured in seconds with the chronometer. Less time indicates better hand dexterity.
The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL)
Time frame: 6 month
The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL): Lawton-IADL scale is a scale consisting of eight questions questioning activities use a phone, food preparation, shopping, housekeeping, laundry, use of public transportation, managing self-medication, and handling finances. Each question is scored as 0 (can not perform or can partially perform) or 1 (can perform) [5]. The total score ranges from 0 (low functionality, dependent) to 8 (high functionality, independent). The Turkish validity and reliability study of the scale was conducted by Işık et al. in 2020.
The Functional Independence Measure (FIM)
Time frame: 6 month
The Functional Independence Measure (FIM): FIM is an 18-item scale that evaluates the degree of independence of the individual in basic physical and cognitive activities in daily life. It has two main sections in which physical/motor function (13 questions) and cognitive function (5 questions) are evaluated. The part of physical/motor function consists of 4 sub-sections in which different activities [self-care performance (eating, grooming, bathing, upper dressing, lower dressing, toileting), sphincter control, transfers, locomotion] are evaluated. The part of cognitive function consists of 2 sub-sections in which communication and social-cognition are evaluated. Each item is scored from 1 to 7, with 'level 1' representing full assistance and 'level 7' being complete independence. The higher the total score, the higher the level of independence. The Turkish adaptation study of the scale was carried out in 2001 by Küçükdeveci et al.
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 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Hemiplegia and Upper Extremity Problem, run by Ufuk 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 1 inclusion and 1 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 18 Jan 2022. 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?
Hand grip and pinch strengths (time frame: 6 month). The study lists 4 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 18 Jan 2022.