Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
High-Repetition Task-Oriented Training Versus High-Intensity Gait Training for Lower Extremity Rehabilitation in Individuals With Chronic Stroke: An Assessor-Blinded Randomized Controlled Trial
The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke.
Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Stroke is a leading cause of long-term disability worldwide, and impaired walking capacity remains one of the most common and persistent limitations in the chronic phase. Although neurodevelopmental treatment (NDT) is widely used in clinical practice, current evidence emphasizes the role of training intensity and task-specific repetition in promoting locomotor recovery. However, comparative evidence regarding the relative effectiveness of high-repetition task-oriented training and high-intensity gait training as adjuncts to conventional therapy in chronic stroke is limited.
This study is designed as an assessor-blinded, three-arm, parallel-group randomized controlled trial. Forty-five individuals with chronic stroke will be randomly allocated in a 1:1:1 ratio to one of three groups (n=15 per group): (1) NDT alone, consisting of 45-minute sessions; (2) NDT combined with high-repetition task-oriented training; or (3) NDT combined with high-intensity gait training. In the combined groups, an additional 30 minutes of the respective training approach will be delivered in each session, resulting in approximately 75 minutes of total treatment time per session. All interventions will be delivered by a single experienced physiotherapist, 3 days per week for 8 weeks (24 sessions in total), at Bingöl State Hospital and the Faculty of Physiotherapy and Rehabilitation of Bingöl University.
The primary outcome is walking capacity assessed with the 6-Minute Walk Test. Secondary outcomes include the Timed Up and Go Test, the modified Dynamic Gait Index, and the 10-Meter Walk Test. All outcome measures will be administered at baseline and at the end of the 8-week intervention period by an independent assessor blinded to group allocation.
Data will be analyzed using repeated-measures analysis of variance to examine time-by-group interaction effects. The study is expected to provide comparative evidence to inform the selection of intensity-based adjunct training strategies in the rehabilitation of walking function in chronic stroke.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Emrah Zirek, Ph. D.
- Telefonnummer: +904262160012
- E-Mail: zireke@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Samet Tatli, MD
- Telefonnummer: +905XXXXXXXXX
- E-Mail: drsamettatli@gmail.com
Studienorte
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Center
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Bingoel, Center, Türkei (türkiye), 12000
- Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir), Zip: 12000
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Kontakt:
- Samet Tatli, MD
- Telefonnummer: +90 XXX XXX XX XX
- E-Mail: drsamettatli@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Diagnosis of first-ever unilateral stroke (ischemic or hemorrhagic) confirmed by clinical and/or radiological findings
- Time since stroke onset of at least 6 months (chronic phase)
- Age between 18 and 75 years
- Ability to walk at least 10 meters independently, with or without an assistive device
- Functional Ambulation Category (FAC) score of 3 or higher
- Sufficient cognitive ability to understand and follow instructions (Mini-Mental State Examination score ≥ 24)
- Willingness to participate and provision of written informed consent
Exclusion Criteria:
- Recurrent stroke or bilateral hemispheric involvement
- Unstable cardiovascular disease or other medical conditions contraindicating high-intensity exercise
- Severe lower extremity spasticity interfering with gait training (Modified Ashworth Scale score > 3)
- Orthopedic, rheumatological, or other neurological conditions affecting gait
- Severe visual or vestibular impairment
- Severe aphasia or cognitive impairment preventing participation in training or assessments
- Participation in another structured rehabilitation or exercise program during the study period
- Botulinum toxin injection to the lower extremity within the last 6 months
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Group 1: Neurodevelopmental Treatment (NDT)
Participants will receive neurodevelopmental treatment alone, delivered in 45-minute sessions, 3 days per week for 8 weeks (24 sessions in total).
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Conventional neurodevelopmental treatment delivered in 45-minute sessions, 3 days per week for 8 weeks, focusing on postural control, weight transfer, selective movement of the lower extremity, and facilitation of normal movement patterns.
All sessions will be delivered by a single experienced physiotherapist.
Andere Namen:
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Experimental: Group 2: NDT + High-Repetition Task-Oriented Training
Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-repetition task-oriented training targeting the lower extremity in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).
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Structured, task-specific lower extremity training performed at high repetition volumes for 30 minutes per session, in addition to neurodevelopmental treatment.
Training includes functional tasks such as sit-to-stand, stepping, and weight-shifting activities, with the number of repetitions and task difficulty progressed individually based on participant performance.
Andere Namen:
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Experimental: Group 3: NDT + High-Intensity Gait Training
Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-intensity gait training in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total).
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Walking-based training performed for 30 minutes per session at high aerobic intensity, in addition to neurodevelopmental treatment.
Training intensity will be progressively adjusted and monitored using target heart rate and ratings of perceived exertion.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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6-Minute Walk Test (6MWT)
Zeitfenster: 8 weeks
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The 6-Minute Walk Test measures the distance (in meters) a participant can walk in 6 minutes along a standardized walkway.
Greater distance indicates better walking capacity.
The test will be administered by an assessor blinded to group allocation.
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8 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Modified Dynamic Gait Index (mDGI)
Zeitfenster: 8 weeks
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The modified Dynamic Gait Index evaluates the ability to modify gait in response to changing task demands across 8 tasks, each scored on three facets (time, level of assistance, and gait pattern).
Total scores range from 0 to 64, with higher scores indicating better dynamic gait performance.
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8 weeks
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10-Meter Walk Test (10MWT)
Zeitfenster: 8 weeks
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The 10-Meter Walk Test measures gait speed (in meters per second) over a 10-meter distance.
Higher speed indicates better walking performance.
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8 weeks
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Lähmung
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Streicheln
- Hemiplegie
Andere Studien-ID-Nummern
- BINGOL-FTR-2026-05-09
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Beschreibung des IPD-Plans
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