Unaffected Hand in Hemiplegia

Hemiplegia Clinical Trial

Official title:

EVALUATION OF THE FUNCTIONAL STATUS OF THE "UNAFFECTED" HAND IN HEMIPLEGIC PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194501
• Other study ID #: 2021-04-04
• Status: Completed
• Start date: March 5, 2021
• Est. completion date: September 5, 2021

Study information

• Verified date: January 2022
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 5, 2021
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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. Exclusion Criteria: 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.

Related Conditions & MeSH terms

• Hemiplegia
• Upper Extremity Problem

Intervention

Other:
• Nine Hole Peg Test, Jamar dynamometer, pinchmeter
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.

Locations

Country	Name	City	State
Turkey	Ufuk University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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 Isik et al. in 2020.	6 month
Primary	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