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

G

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status

Terminated

Conditions

Stroke
Muscle Spasticity

Treatments

Procedure: Passive extension mobilization of the hand and wrist joints

Study type

Interventional

Funder types

Other

Identifiers

NCT04502927
GHR 1020
IDRCB 2019-A02953-54 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Stroke patients with hand spasticity (n=20)
Other group
Treatment:
Procedure: Passive extension mobilization of the hand and wrist joints
Healthy volunteers (n=10)
Other group
Treatment:
Procedure: Passive extension mobilization of the hand and wrist joints

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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