NCT07082036

Brief Summary

Among the repercussions of hemiparesis following stroke, disturbed stability is responsible for a high risk of falls. Picking up objects from the ground, frequently trained in rehabilitation due to its risk of falling and its frequency in daily life, is a task requiring balance. To date, however, it has been little studied. We suggest that stability conditions the asymmetry adopted by patients. We hypothesise that asymmetric support at the expense of the paretic lower limb provides better stability during an unstable functional task (picking up an object from the ground) compared with the symmetrical support traditionally imposed in rehabilitation. Postural control involves stability (maintaining balance despite constraints) and orientation (posture adopted, such as the distribution of supports). Hemiparetic patients show a lack of stability and, with regard to orientation, an asymmetry in the distribution of body weight to the detriment of the paretic limb. Symmetrisation of weight distribution has been one of the predominant concepts in rehabilitation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Nov 2024Nov 2026

Study Start

First participant enrolled

November 5, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

May 21, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

Hemiparetic patientsStabilityOrientationPostural controlStrategyMotion

Outcome Measures

Primary Outcomes (1)

  • stability parameter: the range of the medio-lateral centre of pressure during the object picking up task

    Two forceplate platforms. 3 trials for each condition

    at baseline

Secondary Outcomes (14)

  • Velocity of the centre of pressure

    at baseline

  • Ellipse area of the centre of pressure

    at baseline

  • Range of the centre of pressure

    at baseline

  • Percentage of weight bearing

    at baseline

  • Kinematics parameters

    at baseline

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemiparetic patients following stroke; Healthy subjects (same age, height, weight).

You may qualify if:

  • All:
  • Male or female ≥ 18 years
  • For patients :
  • Haemiparesis after a single unilateral hemispheric Stroke.
  • Stroke ≥ 6 months
  • Asymmetry of support between the 2 lower limbs (distribution of body weight) in a standing position at the expense of the paretic lower limb \> 10%.
  • Able to stand alone, without technical aids or equipment, with feet the width of the pelvis
  • Able to pick up an object from the ground alone (minimum score 3/4 item 9 of the Berg Balance Scale).
  • Patient informed and having signed a consent form
  • For healthy subjects:
  • \- Similar characteristics (in terms of sex, age range and BMI class) to those of one of the patients already included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Raymond Poincaré - APHP

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

ParesisOrientation, Spatial

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Officials

  • Céline Bonnyaud

    Motion Analysis Laboratory, CHU Raymond Poincaré - APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Bonnyaud, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

July 24, 2025

Study Start

November 5, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations