Clinical trial NCT04502927: Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients
Official title: Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Muscle Spasticity
Stroke
Keywords: Muscle Spasticity
Mobilization
Wrist and Hand Complex
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Amplitude values
timeFrame: 1 minute after intervention
measure: Angular velocity values
timeFrame: 1 minute after intervention
Secondary outcomes:
measure: Mean amplitude of the two groups
timeFrame: 1 minute after intervention
measure: Mean angular velocity of the two groups
timeFrame: 1 minute after intervention
measure: Mean amplitude after mobilization with thumb abduction
timeFrame: 1 minute after intervention
measure: Mean angular velocity after mobilization with thumb abduction
timeFrame: 1 minute after intervention
measure: Mean amplitude after mobilization of the fifth finger
timeFrame: 1 minute after intervention
measure: Mean angular velocity after mobilization of the fifth finger
timeFrame: 1 minute after intervention
measure: Pain experienced by stroke patients before mobilisation
timeFrame: 1 minute before intervention
measure: Pain experienced by stroke patients after mobilisation
timeFrame: 1 minute after intervention
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Study officials:
affiliation: GHRMSA hospital
name: Nicolas Winisdoerffer
role: PRINCIPAL_INVESTIGATOR
References: