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Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult (PLATAUTONOMIE)

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ClinicalTrials.gov Identifier: NCT02850731
Recruitment Status : Withdrawn (Organisation problem)
First Posted : August 1, 2016
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

Highly diversified programs of physical activity in older people have shown their effectiveness in terms of improving functional capacities. Only one of these programs, to date, has used a motorized platform. The motorized platform allows the use of sensorimotor programs adapted to this population. Thus, for the user, a combination of motor and sensory capacities necessary to actively control different positions as well as reactions to maintain balance are stimulated, and are as important as psychomotor capabilities to maintain autonomy and the fight against losing independence.

Demonstration of the effectiveness of this type of equipment would propose a new modality of physical activity adapted to this population. Use of this new equipment could allow the possibility of standardizing this activity, whilst continuing to individualize physical activity programs.

Two phases for each group (Intervention/Control):

Phase 1 (day 0 - week 6): 2x1 hour sessions per week using the Hu360® (Intervention group) or an adapted physical activity program (Control group) under supervision of a therapist who will adapt the program according to the progress of the patient, following a standardized procedure (exercises: postural/balance training, strength training for the legs/trunk and coordination and endurance activities) Phase 2 (week 6 - month 6): Physical activity program at home for both groups, performed independently.

Blinded evaluations will be performed at 6 weeks and at 6 months for each group.

The investigators hypothesis is that the use of the motorized platform will allow superior physical performance compared to a traditional physical activity program.


Condition or disease Intervention/treatment Phase
Fragility Device: plate-forme Hu360® Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: plate-forme Hu360®
the innovative technology (plate-forme Hu360®) will be used in the experimental arm
Device: plate-forme Hu360®
the innovative technology (plate-forme Hu360®) will be used in the experimental arm

No Intervention: supervision by a therapist
an adapted physical activity program under supervision of a therapist



Primary Outcome Measures :
  1. Evolution of physical performances using the Score Short Physical Performance Battery [ Time Frame: 6 months ]
    Evolution of physical performances within 6 months estimated by the Score Short Physical Performance Battery



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Ages Eligible for Study:   70 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged between 70-89 years old.
  • Living at home
  • Having at least one fragility criteria (from Fried's 5 criteria), which must include the sedentary criteria.
  • Having a Score SPPB <10
  • Independent mobility
  • MMSE score ≥18
  • BMI between 18 and 40
  • Informed consent to participate in a randomized control trial (physical activity using the motorized platform, Hu360® vs a traditional physical activity program).

Exclusion Criteria:

  • Severe cardiac problems
  • Degenerative neurological conditions
  • Hip/Knee joint replacement less than 6 months before the study.
  • Psychotic disorders or bipolar disorder.
  • Patients who already participate in a regular physical activity program or follow a rehabilitation program.
  • Patients under legal protection and / or unable to give informed consent
  • Already participating in a clinical trial or a study with a physical activity program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850731


Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Pierre Carette, PhD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02850731    
Other Study ID Numbers: 15 7841 16
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No