NCT04782141

Brief Summary

This study investigated how torso and shoulder positioning can help restore coordinated hand movements in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 1, 2021

Last Update Submit

March 3, 2021

Conditions

Keywords

strokemotor coordinationgrip strengthrehabiliatationstabilizationpositioning

Outcome Measures

Primary Outcomes (13)

  • Range of passive movement of the wrist

    The Hand Tutor allows measurements of the range of passive movement of the wrist (in mm).

    up to 10 weeks

  • Range of active movement of the wrist

    The Hand Tutor allows measurements of the range of active movement of the wrist (in mm)

    up to 10 week

  • Wrist extension deficit (mm). The extension deficit refers to the difference between passive and active ROM.

    The Hand Tutor allows measurements of the extension deficit (in mm)

    up to 10 weeks

  • Wrist flexion deficit mm

    The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.

    up to 10 weeks

  • Wrist maximum range of motion (ROM), mm

    The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension.

    up to 10 weeks

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

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

    up to 10 weeks

  • Range of passive movement of the fingers

    The Hand Tutor allows measurements of the passive movement of the fingers (in mm)

    up to 10 weeks

  • Range of active movement of the fingers

    The Hand Tutor allows measurements of the active movement of the fingers (in mm)

    up to 10 weeks

  • Fingers extension deficit mm

    The Hand Tutor allows measurements of the extension deficit (in mm). The extension deficit refers to the difference between passive and active ROM.

    up to 10 weeks

  • Fingers flexion deficit mm

    The Hand Tutor allows measurements of the flexion deficit (in mm). The flexion deficit refers to the difference between passive and active ROM.

    up to 10 weeks

  • Fingers maximum range of motion (ROM), mm

    The Hand Tutor allows measurements of the maximum range of motion (ROM) (in mm), from flexion to extension of each finger.

    up to 10 weeks

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

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

    up to 10 weeks

  • Assessment of the grip strength

    Grip strength, kg (a manusl electronic dynamometr (EH 101) was used for grip strength

    up to 10 weeks

Study Arms (1)

Positioning the trunk and upper limb to improve the coordination the hand.

EXPERIMENTAL

The study investigated the effects of the trunk and upper limb positioning on improving wrist and hand coordination.

Procedure: hand motor coordination in a sitting positinProcedure: hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunkProcedure: hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position

Interventions

The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.

Positioning the trunk and upper limb to improve the coordination the hand.

motor tasks carried out in starting positions: supine with the upper extremity positioned perpendicularly to the trunk; the upper limb in adduction and flexion in the humeral joint, elbow extension, forearm in the intermediate position; elbow, wrist, hand free from stabilization.

Positioning the trunk and upper limb to improve the coordination the hand.

In the supine position, the upper limb was held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.

Positioning the trunk and upper limb to improve the coordination the hand.

Eligibility Criteria

Age20 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Control Group

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, MD

    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
PRINCIPAL INVESTIGATOR
PI Title
PhD; Senior Specjalit of the Rehabilitation Clinc

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

August 5, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations