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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Muscle Spasticity
• Intervention / Treatment: Procedure: Passive extension mobilization of the hand and wrist joints

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mulhouse, France
    • Groupe hospitalier de la région de Mulhouse et Sud Alsace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stroke patients with hand spasticity (n=20)	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.
Other: Healthy volunteers (n=10)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude values	Amplitude values will be calculated with the Dartfish® system	1 minute after intervention
Angular velocity values	Angular velocity values will be calculated with the Dartfish® system	1 minute after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Investigators: Principal Investigator: Nicolas Winisdoerffer, GHRMSA hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Mobilization; Muscle Spasticity; Wrist and Hand Complex
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: GHR 1020; IDRCB 2019-A02953-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No