- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391801
Neuroathletic Training in Stroke Rehabilitation? A Single-blind Randomized Controlled Pilot Study on the Potentials of Neuroathletic Training on Balance Ability in Stroke Outpatient Rehabilitation
Neuroathletic Training in Stroke Rehabilitation - A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design The study design was a monocentric single-blinded randomized controlled pilot study (N=19). Aim of the study was to investigate potential effects of a 4-week outpatient rehabilitation program including 15 minutes of daily neuroathletic training compared to 15 minutes treatment as usual (traditional movement therapy). The primary endpoint was balance ability in stroke outpatient rehabilitation, measured via the German Version of the Berg Balance Scale (BBS) during a pre and post measurement, conducted by one blinded therapist in the years 2021-2022. The pretest of BBS was assessed in all participants on the first day of their rehabilitation program before the start of therapeutic measures. The second and final assessment of BBS was carried out on the last day after completion of all rehabilitation measures. Sample size calculation was based on an initial power analysis.
Population Participants were randomly assigned to the control and intervention groups by a coordinating therapist of the study site via a simple concealed randomization. Participant selection took place ad hoc. Inclusion criteria for the study participation were the main clinical diagnosis of stroke and indication for outpatient rehabilitation including movement therapy as well as adequate fitness to participate in a 4-week movement therapy program. All subjects agreed to participate voluntarily and gave written informed consent. The study was approved by Ethics Committee of the German Sports University Cologne in accordance with the Declaration of Helsinki (Seventh revision, 2013).
Study procedure The neuroathletic training included a structured exercise catalog prepared in advance and performed in a standardized manner for all patients of the intervention group. The conducting therapists received an introduction to carry out neuroathletic training and received all materials necessary for the intervention as well as the standardized training program with the exercise catalogue to perform almost identical training (table 1, Appendix A). All other therapeutic contents were the same for the intervention and control groups. More frequent short training sessions are to be preferred over a few longer ones. Therefore, training was conducted daily for 15 minutes with each patient. The total time of neuroathletic training in the intervention period was ten hours per patient of the intervention group.
Measures and statistical analyses As in the original English version, the German version of the Berg balance scale comprises 14 test items, which can be rated on a 5-point Likert scale from 0 to 4 points. It represents a well-established and valid measure and is considered as the gold standard to assess balance [12]. The total score is calculated by adding the values of each item and is a maximum of 56 points. According to Berg, Wood-Dauphinee, Williams & Maki [1992], persons with a total score of less than 45 points are considered to have impaired balance and are at increased risk of falling. The data analysis was carried out via IBM SPSS Statistics Version 28 (190). Demographic data were analyzed via descriptive statistics. The change in the subjects' ability to balance was analyzed in both groups using the Wilcoxon test. The examination of the values between the control and intervention group were analyzed using the Mann Whitney-U test (significance level α = 5 %) due to the small sample size. Effect sizes were calculated via Cohens d.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Northrhine Westphalia
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Gummersbach, Northrhine Westphalia, Germany, 51643
- Clinic Oberberg - Healthcare facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- main clinical diagnosis of stroke and indication for outpatient rehabilitation including movement therapy as well as adequate fitness to participate in a 4-week movement therapy program
Exclusion Criteria:
- No adequate fitness for participationg in the 4 week intervention time
- no adequate diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Daily 15 Minutes of Neuroathletic training additional to traditional movement therapy in outpatient rehabilitation
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Specific Neuroathletic training exercises were performed to improve balance ability of post stroke patients
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Active Comparator: Control group
Traditional movement therapy in outpatient rehabilitation
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Traditional movement therapy in outpatient rehabilitation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: 4 weeks
|
The BBS comprises 14 activities that the therapist observes and evaluates in relation to balance. A maximum of four points can be awarded for each activity. A maximum score of 56 points can be achieved. The therapist conducts the various activities according to an instructions (manual) and demonstrates them if necessary. Due to the very good reliability and responsiveness the scale can therefore be recommended for follow-up measurements |
4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neuroathletic in Stroke Rehab
- 124/22 (Registry Identifier: Pilot study of specific neuroathletic training on the balance ability of stroke patients in outpatient rehabilitation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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