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

Stroke Clinical Trial

— PHYSIOHAND  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04502927
• Other study ID #: GHR 1020
• Secondary ID: IDRCB 2019-A0295
• Status: Terminated
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: March 18, 2020

Study information

• Verified date: June 2021
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Région de Mulhouse et Sud Alsace	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude values	Amplitude values will be calculated with the Dartfish® system	1 minute after intervention
Primary	Angular velocity values	Angular velocity values will be calculated with the Dartfish® system	1 minute after intervention
Secondary	Mean amplitude of the two groups		1 minute after intervention
Secondary	Mean angular velocity of the two groups		1 minute after intervention
Secondary	Mean amplitude after mobilization with thumb abduction		1 minute after intervention
Secondary	Mean angular velocity after mobilization with thumb abduction		1 minute after intervention
Secondary	Mean amplitude after mobilization of the fifth finger		1 minute after intervention
Secondary	Mean angular velocity after mobilization of the fifth finger		1 minute after intervention
Secondary	Pain experienced by stroke patients before mobilisation	Pain will be assessed by the Visual Analogue Scale (VAS)	1 minute before intervention
Secondary	Pain experienced by stroke patients after mobilisation	Pain will be assessed by the Visual Analogue Scale (VAS)	1 minute after intervention