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Balance capacity in people after stroke

Balance capacity in people after stroke - Balance after stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45141
Enrollment
250
Registered
2016-04-14
Start date
2017-02-10
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebro Vascular Accident (CVA) Stroke

Interventions

During the intervention study, participants will be randomized in one of the three interventions
two interventions consist of dynamic balance training on the C-Mill/3NP (treadmill) and one intervention consist of no training (Inactive Control intervention). Participants will receive dynamic bal

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in the cohort study as a participant that had a stroke, a participant must meet the following criteria: - Having sustained a unilateral minor supratentorial stroke more than 6 months ago with hemiparesis involving the leg. - Consequences of the stroke were not severe enough to get inpatient rehabilitation in a rehabilitation center. - Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories scores 4 or 5. - 18 years or older.;In order to be eligible to participate in the cohort study as a healthy participant, a participant must meet the following criteria: - Not having sustained a stroke. - Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories score 5. - 18 years or older.;In order to be eligible to participate in the intervention study, a participant must meet the following criteria: - Having sustained a unilateral supratentorial stroke more than 6 months ago with hemiparesis involving the leg. - Consequences of the stroke were severe enough to get inpatient rehabilitation in a rehabilitation center. - Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories scores 4 or 5. - 18 years or older.

Exclusion criteria

Exclusion criteria: With regard to the cohort and intervention study, a potential participant who meets any of the following criteria will be excluded from participation: - Any other neurological or musculoskeletal conditions affecting balance. - Current orthopaedic problems; current hip or knee replacement, or limb amputation. - Severe cognitive problems (Montreal Cognitive Assessment

Design outcomes

Primary

MeasureTime frame
To assess the balance capacity in people in the chronic phase after a minor stroke, we will conduct a feet-in-place test, stepping test and step adjustment test on the N-Mill-DFP (treadmill with perturbation and measurement options). In the intervention study, the balance capacity of participants will be assessed pre and post intervention. With regard to the cohort and intervention study, the main study parameters are the Frequency Response Function (FRF; feet-in-place test), the leg angle at stepping foot contact (stepping test) and the foot placement error (step adjustment test). For the cohort study, also the number of falls as registered during the one year follow-up will also be included as main study parameter.

Secondary

MeasureTime frame
With regard to the cohort and intervention study: The secondary study parameter for the feet-in-place test include a human balance control model which is fit onto the experimentally derived FRF, to estimate parameters with a physiological meaning, for instance ankle joint passive stiffness, reflexive properties and neural time delay. The secondary study parameters in the stepping test are the spatiotemporal step variables (i.e. step onset, step length, step duration, step velocity). Furthermore, for stepping in medial lateral direction, the percentage of side steps will be included as study parameter. For the step adjustment test, onset latencies of stepping adjustments and average speed of adjustments will be calculated as secondary study parameters. Other secondary study parameters are the scores on the clinical assessment (i.e. Montreal Cognitive Assessment, Motricity Index, Fugl Meyer Lower Extremity Assessment, 10 meter walking test, Activities-specific Balance Confidence scale, Star Cancellation Test and balance test (Mini-BESTest or Berg Balance Scale)) and body sway and reaction forces for unperturbed standing (eyes open and closed). In addition, the daily activity level will be included as secondary parameter.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)