Chronicity Dependence of a Balance Training in Adults Post-stroke

NCT ID: NCT02673294

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-02-29

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).

Conditions

Stroke, Postural Balance, Virtual Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention (6-12 months)

Participants with a chronicity between 6-12 months

Group Type: EXPERIMENTAL

balance virtual rehabilitation

Intervention Type: OTHER

Intervention (12-24 months)

Participants with a chronicity between 12-24 months

Group Type: EXPERIMENTAL

balance virtual rehabilitation

Intervention Type: OTHER

Intervention (>24 months)

Participants with a chronicity \>24 months

Group Type: EXPERIMENTAL

balance virtual rehabilitation

Intervention Type: OTHER

Interventions

balance virtual rehabilitation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

Hospitales Nisa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HNISA2016-01

Identifier Type: -

Identifier Source: org_study_id