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Clinical Trials/NCT07082036
NCT07082036RecruitingNot Applicable

Study of the Stability of Post-stroke Hemiparetic Patients During a Task Involving Picking up an Object on the Ground. Reflection Questioning the Conventional Rehabilitation of These Patients

Assistance Publique - Hôpitaux de Paris1 site in 1 country72 target enrollmentStarted: November 5, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
72
Locations
1
Primary Endpoint
stability parameter: the range of the medio-lateral centre of pressure during the object picking up task

Study Overview

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.

Detailed Description

To analyse the stability of hemiparetic stroke patients when picking up an object on the ground in a spontaneous condition compared with a condition of imposed support symmetry.

To analyse and compare the stability, spontaneous symmetry and duration of picking up the object in a complex situation (distant target) compared with the near target in stroke patients and healthy subjects.

To explore strategy and performance of picking up the object regarding clinical outcomes (falls, sensori-motor impairments, balance..) To compare strategy of patients with right and left stroke.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: at baseline

Two forceplate platforms. 3 trials for each condition

Secondary Outcomes

  • Ellipse area of the centre of pressure(at baseline)
  • Kinematics parameters(at baseline)
  • Clinical scales-Medical Research Council(at baseline)
  • Clinical scales -Neglect and lateropulsion scale(at baseline)
  • Functional reach test(at baseline)
  • Velocity of the centre of pressure(at baseline)
  • Range of the centre of pressure(at baseline)
  • Percentage of weight bearing(at baseline)
  • Clinical scales - Berg balance scale(at baseline)
  • Questionnaires : Confidence perception and stability perception during the object picking up task(at baseline)
  • Clinical scales-Nottingham Sensory Assessment(at baseline)
  • Activities-Specific Balance Confidence(at baseline)
  • Clinical scales-Modified Ashworth(at baseline)
  • Cognitive scale : Batterie Rapide d'Efficience Frontale(at baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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