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

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04502927
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Days): 8
• Patients Per Site Per Month: 7.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity; Stroke	Procedure: Passive extension mobilization of the hand and wrist joints	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients
• Actual Study Start Date: Mar 10, 2020
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: Mar 18, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Amplitude values [1 minute after intervention]

   Amplitude values will be calculated with the Dartfish® system

2. Angular velocity values [1 minute after intervention]

   Angular velocity values will be calculated with the Dartfish® system

Secondary Outcome Measures

1. Mean amplitude of the two groups [1 minute after intervention]

2. Mean angular velocity of the two groups [1 minute after intervention]

3. Mean amplitude after mobilization with thumb abduction [1 minute after intervention]

4. Mean angular velocity after mobilization with thumb abduction [1 minute after intervention]

5. Mean amplitude after mobilization of the fifth finger [1 minute after intervention]

6. Mean angular velocity after mobilization of the fifth finger [1 minute after intervention]

7. Pain experienced by stroke patients before mobilisation [1 minute before intervention]

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

8. Pain experienced by stroke patients after mobilisation [1 minute after intervention]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier de la Région de Mulhouse et Sud Alsace	Mulhouse		France

Sponsors and Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Investigators

• Principal Investigator: Nicolas Winisdoerffer, GHRMSA hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• ClinicalTrials.gov Identifier: NCT04502927
• Other Study ID Numbers: GHR 1020; IDRCB 2019-A02953-54
• First Posted: Aug 6, 2020
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: Muscle Spasticity; Mobilization; Wrist and Hand Complex
• Additional relevant MeSH terms: Muscle Spasticity; Stroke

Study Results

No Results Posted as of Jul 8, 2021