- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07709130
Rhythmic Auditory Stimulation and Dual-task Gait Training in Chronic Stroke
11. juli 2026 oppdatert av: Seda Karaca, Recep Tayyip Erdogan University
Combined Rhythmic Auditory Stimulation and Dual-task Gait Training in Individuals With Chronic Stroke: a Pre-post Study With Exploratory Age-stratified Analyses
Rhythmic auditory stimulation and dual-task gait training may improve post-stroke mobility, but evidence regarding integrated programmes and age-related differences in treatment response remains limited.
The aim of the study is to evaluate changes in mobility, balance, motor dual-task performance, concern about falling, and health-related quality of life after a six-week combined programme, and to explore whether responses differed across age strata.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This prospective single-group pre-post study included individuals with chronic stroke.
Participants completed supervised rhythmic auditory stimulation and progressively intensified motor dual-task gait training three times weekly for six weeks.
Outcomes included motor dual-task performance, Timed Up and Go, bilateral single-leg stance, Mini-BESTest, Falls Efficacy Scale-International, and SF-36.
An independent assessor, unaware of previous scores and age-stratum allocation, conducted baseline and post-intervention assessments.
Prespecified exploratory analyses compared changes across age strata.
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Rize, Tyrkia (Türkiye)
- Recep Tayyip Erdogan University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- age ≥45 years
- stroke ≥6 months previously
- ability to walk at least 10 m independently or with minimal assistance
- sufficient hearing to follow rhythmic auditory cues
Exclusion Criteria:
- advanced aphasia
- severe neglect, cognitive impairment,
- marked visual impairment,
- severe spasticity (Modified Ashworth Scale score15 ≥3)
- severe cardiopulmonary disease
- vestibular dysfunction
- an orthopaedic condition limiting walking
- progressive neurological disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Stroke Group
Participants completed a supervised six-week programme comprising three 30-minute sessions per week (18 sessions; planned dose, 540 minutes).
During each session, they synchronized their steps with a metronome while performing tandem walking with progressively demanding object-carrying tasks.
Participants maintained their usual walking speed and were instructed to give equal attention to gait and the concurrent motor task.
Progression was designed by the research team in accordance with general motor-learning principles and involved predefined weekly increases in metronome tempo and concurrent motor-task complexity.
|
The intervention combined RAS with progressively intensified motor dual-task gait training.6
Participants completed a supervised six-week programme comprising three 30-minute sessions per week (18 sessions; planned dose, 540 minutes).
During each session, they synchronized their steps with a metronome while performing tandem walking with progressively demanding object-carrying tasks.
Participants maintained their usual walking speed and were instructed to give equal attention to gait and the concurrent motor task.
Progression was designed by the research team in accordance with general motor-learning principles and involved predefined weekly increases in metronome tempo and concurrent motor-task complexity.
provided that the preceding stage had been completed safely.
All sessions were delivered individually by the same licensed physiotherapist experienced in neurology.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Motor dual-task performance
Tidsramme: at baseline and after the six-week programme
|
Participants completed a 10-m walk at their comfortable speed under single-task and motor dual-task conditions.
In the dual-task condition, they carried a ball while walking and were instructed to give equal attention to both tasks.
Three trials were performed under each condition, and mean completion time was used in the analysis.
Positive values indicated greater dual-task interference.
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at baseline and after the six-week programme
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Functional mobility
Tidsramme: at baseline and after the six-week programme
|
Functional mobility was assessed using the Timed Up and Go test, with shorter completion times indicating better performance.
One familiarization trial preceded the timed assessment.
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at baseline and after the six-week programme
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Balance
Tidsramme: at baseline and after the six-week programme
|
Dynamic balance was assessed using the 14-item Mini-BESTest, which evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Total scores range from 0 to 28, with higher scores indicating better balance.
Static balance was assessed bilaterally using the Single-Leg Stance Test.
Two trials were performed on each side, and the longest duration before foot contact, stance-foot movement, or loss of balance was recorded.
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at baseline and after the six-week programme
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
15. januar 2026
Primær fullføring (Faktiske)
15. mai 2026
Studiet fullført (Faktiske)
15. mai 2026
Datoer for studieregistrering
Først innsendt
11. juli 2026
Først innsendt som oppfylte QC-kriteriene
11. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026/01-1781
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