NCT05008302

Brief Summary

The aim of the study was to analyze the importance of the position of the body and the examined upper limb on the parameters of movement coordination and hand grip strength in various age groups of people after a stroke and healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable stroke

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

April 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 10, 2021

Last Update Submit

August 10, 2021

Conditions

Keywords

strokeagegrip strengthcoordination movementstabilization

Outcome Measures

Primary Outcomes (5)

  • Maximum range of movement of the wrist [mm]

    Hand Tutor allows measurements of the maximum range of motion (ROM).

    up to 1 week

  • Frequency of wrist movement (flexion to extension), cycles#/sec

    The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles

    up to 1 week

  • Frequency of 1st, 2nd, 3rd, 4th, 5th finger movement (flexion to extension), cycles#/sec

    The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles

    up to 1 week

  • 1st, 2nd, 3rd, 4th, 5th finger maximum range of motion (ROM), [mm]

    The Hand Tutor allows measurements of the maximum range of motion (ROM).

    up to 1 week

  • Assessment of the grip strength

    Grip strength, kg (a manual electronic dynamometer (EH 101) was used for grip strength measurement (error of measurement, 0.5 kg/lb)

    up to 1 week

Study Arms (1)

To improve the coordination of the wrist and hand after stroke in three age groups.

EXPERIMENTAL

The test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).

Procedure: hand motor coordination in a sitting positin

Interventions

Before each test, the patient was instructed on how the exercise should be done. The test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).

Also known as: hand motor coordination in a supine position
To improve the coordination of the wrist and hand after stroke in three age groups.

Eligibility Criteria

Age22 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Olczak

Warsaw, Masovian District, 04-141, Poland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anna Olczak, PhD

    Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD; Senior Specjalit of the Rehabilitation Clinc

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 17, 2021

Study Start

April 10, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations