StrokeNCT06391801
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
A study testing Neuroathletic training and Traditional movement therapy in outpatient rehabilitation in people with Stroke and Balance Postural, run by German Sport University, Cologne at 1 site in Germany.
Trial summary
Based on anecdotal evidence, neuroathletic training is described as effective for target groups in performance sports, leisure sports and movement therapy. Neuroathletic training is being integrated more and more into practical fields of training, coaching education and therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Balance Postural
- What is being tested?
- Neuroathletic training and Traditional movement therapy in outpatient rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No adequate fitness for participationg in the 4 week intervention time
- no adequate diagnosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic Oberberg - Healthcare facility
Gummersbach, North Rhine-Westphalia, 51643
About this study
Official title: Neuroathletic Training in Stroke Rehabilitation - A Pilot Study
Based on anecdotal evidence, neuroathletic training is described as effective for target groups in performance sports, leisure sports and movement therapy. Neuroathletic training is being integrated more and more into practical fields of training, coaching education and therapy. In addition to athletic objectives, it emphasizes to address central nervous system movement control and specific perception exercises, which are included in specific training sessions. It is gaining attention through literature and an increasing number of workshops for practitioners, yet scientific evidence to support effectiveness of therapeutic approaches is lacking. Only few research findings show positive effects in the context of specific neuroathletic exercises. With respect to patients in stroke rehabilitation, exercises to stimulate the visual and vestibular systems were found to be effective for movement rehabilitation. Exploring neuroathletic perceptual exercises to improve balance seems to be promising for the target group. Stroke patients experience deficits in balance and losses in motor function during activities of daily living, therefore temporal precision activity-related stimuli could provide a useful complement of movement therapy to provide targeted support of neuronal plasticity, in order to restore functions over time. Outpatient rehabilitation movement therapy aims to promote physical functions that are important in everyday life, including coordination and balance tasks, in order to enable independent and safe movement. To explore neuroathletic training potentials on balance ability in stroke rehabilitation, a single-blinded controlled pilot study was conducted in a stroke outpatient rehabilitation program.
Read the 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.
- Conditions
- Stroke, Balance Postural
- Being tested
- Neuroathletic training, Traditional movement therapy in outpatient rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroathletic trainingBehavioural
Specific Neuroathletic training exercises were performed to improve balance ability of post stroke patients
Traditional movement therapy in outpatient rehabilitationBehavioural
Traditional movement therapy in outpatient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Daily 15 Minutes of Neuroathletic training additional to traditional movement therapy in outpatient rehabilitation Receives: Behavioral: Neuroathletic training |
| Control group | Active comparator | Traditional movement therapy in outpatient rehabilitation Receives: Behavioral: Traditional movement therapy in outpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Sport University, Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Isabel Stolz, German Sport University, Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391801
- Sponsor's protocol ID
- Neuroathletic in Stroke Rehab
- Other IDs
- 124/22
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants in this study did not give written consent for their personal data to be shared publicly; therefore, so due to the sensitive nature of the research, supporting data is unavailable.
Publications
Evers J, Stolz I, Klein M. Neuroathletic training in stroke rehabilitation? A single-blind randomized controlled pilot study on the potential of neuroathletic training for balance ability in stroke outpatient rehabilitation. BMC Res Notes. 2024 Dec 12;17(1):358. doi: 10.1186/s13104-024-07022-0.
PubMed 39668364
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroathletic Training in Stroke Rehabilitation - A Pilot Study
- ClinicalTrials.gov ID
- NCT06391801
- Acronym / sponsor ID
- Neuroathletic in Stroke Rehab
- Conditions
- Stroke, Balance Postural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German Sport University, CologneUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Apr 2024 (actual)
- 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.
Based on anecdotal evidence, neuroathletic training is described as effective for target groups in performance sports, leisure sports and movement therapy. Neuroathletic training is being integrated more and more into practical fields of training, coaching education and therapy. In addition to athletic objectives, it emphasizes to address central nervous system movement control and specific perception exercises, which are included in specific training sessions. It is gaining attention through literature and an increasing number of workshops for practitioners, yet scientific evidence to support effectiveness of therapeutic approaches is lacking. Only few research findings show positive effects in the context of specific neuroathletic exercises. With respect to patients in stroke rehabilitation, exercises to stimulate the visual and vestibular systems were found to be effective for movement rehabilitation. Exploring neuroathletic perceptual exercises to improve balance seems to be promising for the target group. Stroke patients experience deficits in balance and losses in motor function during activities of daily living, therefore temporal precision activity-related stimuli could provide a useful complement of movement therapy to provide targeted support of neuronal plasticity, in order to restore functions over time. Outpatient rehabilitation movement therapy aims to promote physical functions that are important in everyday life, including coordination and balance tasks, in order to enable independent and safe movement. To explore neuroathletic training potentials on balance ability in stroke rehabilitation, a single-blinded controlled pilot study was conducted in a stroke outpatient rehabilitation program.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Neuroathletic trainingDaily 15 Minutes of Neuroathletic training additional to traditional movement therapy in outpatient rehabilitation |
| Control group | Active comparator | Behavioral: Traditional movement therapy in outpatient rehabilitationTraditional movement therapy in outpatient rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- No adequate fitness for participationg in the 4 week intervention time
- no adequate diagnosis
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 |
|---|---|---|
| Neuroathletic trainingSpecific Neuroathletic training exercises were performed to improve balance ability of post stroke patients | Behavioural | Intervention group |
| Traditional movement therapy in outpatient rehabilitationTraditional movement therapy in outpatient rehabilitation | Behavioural | Control group |
Primary outcome
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
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 1 May 2024.
- Derived from this study: PubMed 39668364Evers J, Stolz I, Klein M. Neuroathletic training in stroke rehabilitation? A single-blind randomized controlled pilot study on the potential of neuroathletic training for balance ability in stroke outpatient rehabilitation. BMC Res Notes. 2024 Dec 12;17(1):358. doi: 10.1186/s13104-024-07022-0.
- Individual participant dataSharing planned: No. The participants in this study did not give written consent for their personal data to be shared publicly; therefore, so due to the sensitive nature of the research, supporting data is unavailable.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroathletic training and Traditional movement therapy in outpatient rehabilitation in people with Stroke and Balance Postural, run by German Sport University, Cologne at 1 site in Germany.
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 1 inclusion and 2 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Berg Balance Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391801, which also lists 1 linked publication.
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 1 May 2024.