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
About this trial
This is an interventional treatment trial for Stroke, Postural Balance, Virtual Rehabilitation
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.
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
NCT ID
NCT02673294
First Posted
February 1, 2016
Last Updated
February 3, 2016
Sponsor
Hospitales Nisa
Collaborators
Universitat Politècnica de València
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
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