Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391801
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2024-04-25
Brief Title:
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
Sponsor:
German Sport University Cologne
Organization:
German Sport University Cologne
Study Overview
Official Title:
Neuroathletic Training in Stroke Rehabilitation - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 N19 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 amp 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 subjects39 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
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 amp 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 subjects39 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12422 | REGISTRY | Pilot study of specific neuroathletic training on the balance ability of stroke patients in outpatient rehabilitation | None |