Stroke, Postural Balance, Virtual RehabilitationNCT02673294
Chronicity Dependence of a Balance Training in Adults Post-stroke
A study testing balance virtual rehabilitation in people with Stroke, Postural Balance, Virtual Rehabilitation, run by Hospitales Nisa.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke, Postural Balance, Virtual Rehabilitation
- What is being tested?
- balance virtual rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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).
- Being tested
- balance virtual rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance virtual rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| intervention (6-12 months) | Experimental | Participants with a chronicity between 6-12 months Receives: Other: balance virtual rehabilitation |
| Intervention (12-24 months) | Experimental | Participants with a chronicity between 12-24 months Receives: Other: balance virtual rehabilitation |
| Intervention (>24 months) | Experimental | Participants with a chronicity >24 months Receives: Other: balance virtual rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Berg Scale
Measured: up to 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Postural Balance, Virtual RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Nisa
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673294
- Sponsor's protocol ID
- HNISA2016-01
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronicity Dependence of a Balance Training in Adults Post-stroke
- ClinicalTrials.gov ID
- NCT02673294
- Acronym / sponsor ID
- HNISA2016-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospitales NisaUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention (6-12 months) | Experimental | Other: balance virtual rehabilitationParticipants with a chronicity between 6-12 months |
| Intervention (12-24 months) | Experimental | Other: balance virtual rehabilitationParticipants with a chronicity between 12-24 months |
| Intervention (>24 months) | Experimental | Other: balance virtual rehabilitationParticipants with a chronicity >24 months |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance virtual rehabilitation | Other | Intervention (12-24 months), Intervention (>24 months), intervention (6-12 months) |
Primary outcome
Balance Berg Scale
Time frame: up to 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing balance virtual rehabilitation in people with Stroke, Postural Balance, Virtual Rehabilitation, run by Hospitales Nisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Berg Scale (time frame: up to 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.