Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

NCT ID: NCT04502927

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-03-18

Brief Summary

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The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.

Secondary objectives:

* To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
* To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
* To assess pain due to mobilization in stroke patients.

Detailed Description

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Conduct of research:

The realization of the measures will take place at the GHRMSA rehabilitation department.

After receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish system which will allow analysis of the primary endpoint.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

Conditions

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Muscle Spasticity Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Stroke patients with hand spasticity (n=20)

Group Type OTHER

Passive extension mobilization of the hand and wrist joints

Intervention Type PROCEDURE

The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

Healthy volunteers (n=10)

Group Type OTHER

Passive extension mobilization of the hand and wrist joints

Intervention Type PROCEDURE

The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

Interventions

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Passive extension mobilization of the hand and wrist joints

The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* First stroke diagnosed less than 3 months ago
* Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor subscale with a score ≤45
* Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1
* Written informed consent


* Age ≥ 18 years old
* Written informed consent

Exclusion Criteria

\- None

Eligibility criteria of healthy volunteers:


\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Winisdoerffer

Role: PRINCIPAL_INVESTIGATOR

GHRMSA hospital

Locations

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Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB 2019-A02953-54

Identifier Type: OTHER

Identifier Source: secondary_id

GHR 1020

Identifier Type: -

Identifier Source: org_study_id

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