- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07709130
Rhythmic Auditory Stimulation and Dual-task Gait Training in Chronic Stroke
11 juli 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
46
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rize, Turkiet (Türkiye)
- Recep Tayyip Erdogan University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Motor dual-task performance
Tidsram: at baseline and after the six-week programme
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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
Tidsram: at baseline and after the six-week programme
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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
Tidsram: at baseline and after the six-week programme
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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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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 januari 2026
Primärt slutförande (Faktisk)
15 maj 2026
Avslutad studie (Faktisk)
15 maj 2026
Studieregistreringsdatum
Först inskickad
11 juli 2026
Först inskickad som uppfyllde QC-kriterierna
11 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026/01-1781
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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