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Recruiting NCT07082036

Stability of Hemiparetic Patients During a Daily Complex Task

Observational Hemiparesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hemiparesis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • stability parameter: the range of the medio-lateral centre of pressure during the object picking up task [Time frame: at baseline]
Secondary outcome measures (12)
  • Velocity of the centre of pressure [Time frame: at baseline]
  • Ellipse area of the centre of pressure [Time frame: at baseline]
  • Range of the centre of pressure [Time frame: at baseline]
  • Percentage of weight bearing [Time frame: at baseline]
  • Kinematics parameters [Time frame: at baseline]
  • Questionnaires : Confidence perception and stability perception during the object picking up task [Time frame: at baseline]
  • Clinical scales - Berg balance scale [Time frame: at baseline]
  • Clinical scales-Medical Research Council [Time frame: at baseline]
  • Clinical scales-Modified Ashworth [Time frame: at baseline]
  • Clinical scales-Nottingham Sensory Assessment [Time frame: at baseline]
  • Clinical scales -Neglect and lateropulsion scale [Time frame: at baseline]
  • Cognitive scale : Batterie Rapide d'Efficience Frontale [Time frame: at baseline]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU Raymond Poincaré - APHP — Garches

Identifiers

NCT: NCT07082036 · APHP230812 · 2024-A00043-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗