NCT04889612

Brief Summary

This study aimed to assess how stabilization of the trunk and the upper extremity can change the parameters of hand/wrist motor coordination and grip strength in dominant and non-dominant paretic upper limb, in post-stroke patients and neurologically healthy subjects.

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 Aug 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

August 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 11, 2021

Last Update Submit

May 17, 2021

Conditions

Stroke

Keywords

dominant handnon-dominant handcoordinationgrip strengthstabilizationstroke

Outcome Measures

Primary Outcomes (5)

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

    The Hand Tutor allows measurements the speed or frequency (i.e., the number of cycles per second, where one cycle represents the movement from flexion to contraction).

    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 per second, where one cycle represents the movement from flexion to contraction).

    up to 1 week

  • Wrist maximum range of motion (ROM) [mm]

    The Hand Tutor allows measurements of the maximum range of motion (ROM). ROM is a sum of the wrist flexion or extension angles (mm). ROM is a sum of all the finger flexion or extension angles (i.e. at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints), mm.

    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). ROM is a sum of the wrist flexion or extension angles (mm). ROM is a sum of all the finger flexion or extension angles (i.e. at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints), mm.

    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)

motor coordination and grip strength in dominant/non-dominant hand

EXPERIMENTAL

Dominant and non-dominant hand motor coordination and grip strength were tested in the stable position of the trunk and the upper arm, in post-stroke patients (study group) and in healthy subjects (control group).

Procedure: hand motor coordination in a sitting positinProcedure: hand motor coordination in a supine position

Interventions

hand motor coordination in a sitting positinPROCEDURE

The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand. After putting the glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.

motor coordination and grip strength in dominant/non-dominant hand
hand motor coordination in a supine positionPROCEDURE

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, wrist and hand free). After putting the Hand Tutor glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.

motor coordination and grip strength in dominant/non-dominant hand

Eligibility Criteria

Age20 Years - 91 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

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

    Rehabilitation Clinic, 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

May 11, 2021

First Posted

May 17, 2021

Study Start

August 5, 2019

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)