NCT04502927

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

8 days

First QC Date

August 3, 2020

Last Update Submit

July 7, 2021

Conditions

Muscle SpasticityStroke

Keywords

Muscle SpasticityMobilizationWrist and Hand Complex

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Stroke patients with hand spasticity (n=20)

OTHER
Procedure: Passive extension mobilization of the hand and wrist joints

Healthy volunteers (n=10)

OTHER
Procedure: Passive extension mobilization of the hand and wrist joints

Interventions

Passive extension mobilization of the hand and wrist jointsPROCEDURE

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.

Healthy volunteers (n=10)Stroke patients with hand spasticity (n=20)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- None
  • Eligibility criteria of healthy volunteers:
  • Age ≥ 18 years old
  • Written informed consent
  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Mulhouse, France

Location

MeSH Terms

Conditions

Muscle SpasticityStroke

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nicolas Winisdoerffer

    GHRMSA hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 6, 2020

Study Start

March 10, 2020

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)