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

Primary Purpose

Muscle Spasticity, Stroke

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Passive extension mobilization of the hand and wrist joints

About this trial

This is an interventional other trial for Muscle Spasticity focused on measuring Muscle Spasticity, Mobilization, Wrist and Hand Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligibility criteria of stroke patients with hand spasticity:

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

Exclusion Criteria:

- None

Eligibility criteria of healthy volunteers:

Inclusion criteria:

Age ≥ 18 years old
Written informed consent

Exclusion Criteria:

- None

Sites / Locations

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Stroke patients with hand spasticity (n=20)

Healthy volunteers (n=10)

Arm Description

Outcomes

Primary Outcome Measures

Amplitude values

Amplitude values will be calculated with the Dartfish® system

Angular velocity values

Angular velocity values will be calculated with the Dartfish® system

Secondary Outcome Measures

Mean amplitude of the two groups

Mean angular velocity of the two groups

Mean amplitude after mobilization with thumb abduction

Mean angular velocity after mobilization with thumb abduction

Mean amplitude after mobilization of the fifth finger

Mean angular velocity after mobilization of the fifth finger

Pain experienced by stroke patients before mobilisation

Pain will be assessed by the Visual Analogue Scale (VAS)

Pain experienced by stroke patients after mobilisation

Pain will be assessed by the Visual Analogue Scale (VAS)

Full Information

NCT ID

NCT04502927

First Posted

August 3, 2020

Last Updated

July 7, 2021

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

1. Study Identification

Unique Protocol Identification Number

NCT04502927

Brief Title

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

Acronym

PHYSIOHAND

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

recruitement issues related to COVID-19

Study Start Date

March 10, 2020 (Actual)

Primary Completion Date

March 18, 2020 (Actual)

Study Completion Date

March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Spasticity, Stroke

Keywords

Muscle Spasticity, Mobilization, Wrist and Hand Complex

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stroke patients with hand spasticity (n=20)

Arm Type

Other

Arm Title

Healthy volunteers (n=10)

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

Passive extension mobilization of the hand and wrist joints

Intervention Description

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.

Primary Outcome Measure Information:

Title

Amplitude values

Description

Amplitude values will be calculated with the Dartfish® system

Time Frame

1 minute after intervention

Title

Angular velocity values

Description

Angular velocity values will be calculated with the Dartfish® system

Time Frame

1 minute after intervention

Secondary Outcome Measure Information:

Title

Mean amplitude of the two groups

Time Frame

1 minute after intervention

Title

Mean angular velocity of the two groups

Time Frame

1 minute after intervention

Title

Mean amplitude after mobilization with thumb abduction

Time Frame

1 minute after intervention

Title

Mean angular velocity after mobilization with thumb abduction

Time Frame

1 minute after intervention

Title

Mean amplitude after mobilization of the fifth finger

Time Frame

1 minute after intervention

Title

Mean angular velocity after mobilization of the fifth finger

Time Frame

1 minute after intervention

Title

Pain experienced by stroke patients before mobilisation

Description

Pain will be assessed by the Visual Analogue Scale (VAS)

Time Frame

1 minute before intervention

Title

Pain experienced by stroke patients after mobilisation

Description

Pain will be assessed by the Visual Analogue Scale (VAS)

Time Frame

1 minute after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility criteria of stroke patients with hand spasticity: 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 Exclusion Criteria: - None Eligibility criteria of healthy volunteers: Inclusion criteria: Age ≥ 18 years old Written informed consent Exclusion Criteria: - None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Winisdoerffer

Organizational Affiliation

GHRMSA hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

City

Mulhouse

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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