Chronicity Dependence of a Balance Training in Adults Post-stroke

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).

Study Overview

• Status: Completed
• Conditions: Stroke, Postural Balance, Virtual Rehabilitation
• Intervention / Treatment: Other: balance virtual rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Balance Berg Scale	up to 1-month follow-up

Collaborators and Investigators

• Sponsor: Hospitales Nisa
• Collaborators: Universitat Politècnica de València

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HNISA2016-01