Chronicity Dependence of a Balance Training in Adults Post-stroke

NCT02673294 | Completed

• 1 other identifier: HNISA2016-01
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Balance Berg Scale

  up to 1-month follow-up

Study Arms (3)

intervention (6-12 months)

EXPERIMENTAL

Participants with a chronicity between 6-12 months

Other: balance virtual rehabilitation

Intervention (12-24 months)

EXPERIMENTAL

Participants with a chronicity between 12-24 months

Other: balance virtual rehabilitation

Intervention (>24 months)

EXPERIMENTAL

Participants with a chronicity \>24 months

Other: balance virtual rehabilitation

Interventions

balance virtual rehabilitation OTHER

Intervention (12-24 months); Intervention (>24 months); intervention (6-12 months)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitales Nisa: lead
• Universitat Politècnica de València: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2016-02