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

Not Applicable

Terminated

• Conditions: Stroke; Muscle Spasticity
• Interventions: Procedure: Passive extension mobilization of the hand and wrist joints

• Registration Number: NCT04502927
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke patients with hand spasticity (n=20)	Passive extension mobilization of the hand and wrist joints	-
Healthy volunteers (n=10)	Passive extension mobilization of the hand and wrist joints	-

Primary Outcome Measures

Name	Time	Method
Amplitude values	1 minute after intervention	Amplitude values will be calculated with the Dartfish® system
Angular velocity values	1 minute after intervention	Angular velocity values will be calculated with the Dartfish® system

Secondary Outcome Measures

Name	Time	Method
Mean angular velocity after mobilization with thumb abduction	1 minute after intervention
Mean amplitude after mobilization of the fifth finger	1 minute after intervention
Pain experienced by stroke patients after mobilisation	1 minute after intervention	Pain will be assessed by the Visual Analogue Scale (VAS)
Mean amplitude of the two groups	1 minute after intervention
Mean angular velocity of the two groups	1 minute after intervention
Mean amplitude after mobilization with thumb abduction	1 minute after intervention
Mean angular velocity after mobilization of the fifth finger	1 minute after intervention
Pain experienced by stroke patients before mobilisation	1 minute before intervention	Pain will be assessed by the Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace; 🇫🇷 Mulhouse, France