NCT05194501

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 3, 2022

Last Update Submit

January 3, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    6 month

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 18, 2022

Study Start

March 5, 2021

Primary Completion

September 5, 2021

Study Completion

September 5, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations