search
Back to results

Chronicity Dependence of a Balance Training in Adults Post-stroke

Primary Purpose

Stroke, Postural Balance, Virtual Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
balance virtual rehabilitation
Sponsored by
Hospitales Nisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Postural Balance, Virtual Rehabilitation

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 50 and ≤ 65 years old
  • Chronicity > six months
  • Fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23
  • Ability to walk 10 meters indoors with or without technical orthopaedic aids.

Exclusion Criteria:

  • Impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45
  • Unilateral spatial neglect
  • Ataxia or any other cerebellar symptom
  • Severe auditory or visual impairments
  • Motional or behavioural circumstances that impede adequate collaboration.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    intervention (6-12 months)

    Intervention (12-24 months)

    Intervention (>24 months)

    Arm Description

    Participants with a chronicity between 6-12 months

    Participants with a chronicity between 12-24 months

    Participants with a chronicity >24 months

    Outcomes

    Primary Outcome Measures

    Balance Berg Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2016
    Last Updated
    February 3, 2016
    Sponsor
    Hospitales Nisa
    Collaborators
    Universitat Politècnica de València
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02673294
    Brief Title
    Chronicity Dependence of a Balance Training in Adults Post-stroke
    Official Title
    Chronicity Dependence of a Balance Training in Adults Post-stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospitales Nisa
    Collaborators
    Universitat Politècnica de València

    4. Oversight

    5. Study Description

    Brief Summary
    The level of stroke chronicity has been proposed as an influential variable related to functional balance. However, little is known about the effect of this variable on the effectiveness and maintenance of gains of physical therapy interventions on balance. The objective of this study is to determine the influence of time since injury on the rehabilitation of balance after stroke. Participants will be assigned to a least (6-12 months), a moderate (12-24 months), or a most chronic (> 24 months) group. All the participants will train for 20 one-hour sessions, administered three to five times a week, combining conventional physical therapy exercises and customized exercises interfaced on a balance board that promotes the training of the ankle and hip strategies. Participants will be assessed before, after the intervention, and one month later with a posturography test (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test, Timed Up-and-Go Test, and the 10-meter Walking Test).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Postural Balance, Virtual Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention (6-12 months)
    Arm Type
    Experimental
    Arm Description
    Participants with a chronicity between 6-12 months
    Arm Title
    Intervention (12-24 months)
    Arm Type
    Experimental
    Arm Description
    Participants with a chronicity between 12-24 months
    Arm Title
    Intervention (>24 months)
    Arm Type
    Experimental
    Arm Description
    Participants with a chronicity >24 months
    Intervention Type
    Other
    Intervention Name(s)
    balance virtual rehabilitation
    Primary Outcome Measure Information:
    Title
    Balance Berg Scale
    Time Frame
    up to 1-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 50 and ≤ 65 years old Chronicity > six months Fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23 Ability to walk 10 meters indoors with or without technical orthopaedic aids. Exclusion Criteria: Impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45 Unilateral spatial neglect Ataxia or any other cerebellar symptom Severe auditory or visual impairments Motional or behavioural circumstances that impede adequate collaboration.

    12. IPD Sharing Statement

    Learn more about this trial

    Chronicity Dependence of a Balance Training in Adults Post-stroke

    We'll reach out to this number within 24 hrs