Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronicity Dependence of a Balance Training in Adults Post-stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673294
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
Universitat Politècnica de València
Information provided by (Responsible Party):
Hospitales Nisa

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).

Condition or disease Intervention/treatment Phase
Stroke, Postural Balance, Virtual Rehabilitation Other: balance virtual rehabilitation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronicity Dependence of a Balance Training in Adults Post-stroke
Study Start Date : February 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: intervention (6-12 months)
Participants with a chronicity between 6-12 months
Other: balance virtual rehabilitation
Experimental: Intervention (12-24 months)
Participants with a chronicity between 12-24 months
Other: balance virtual rehabilitation
Experimental: Intervention (>24 months)
Participants with a chronicity >24 months
Other: balance virtual rehabilitation



Primary Outcome Measures :
  1. Balance Berg Scale [ Time Frame: up to 1-month follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Layout table for additonal information
Responsible Party: Hospitales Nisa
ClinicalTrials.gov Identifier: NCT02673294     History of Changes
Other Study ID Numbers: HNISA2016-01
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases