- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07913295
Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients
Comparative Effect of Dual Task Training and Rhythmic Stabilization on Pain, Balance, Proprioception and Physical Function in Patients With Knee Osteoarthritis
Knee osteoarthritis (KOA) is a degenerative joint condition that causes pain, stiffness, reduced proprioception, impaired balance, and decreased physical function. This study aims to compare the effects of Dual Task Training and Rhythmic Stabilization Training on balance, proprioception, and physical function in patients with KOA. A randomized clinical trial will be conducted using convenient sampling, with participants randomly allocated into two groups. Both groups will receive a 15-minute hot pack followed by their respective interventions, three times per week for six weeks,12 sessions.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan
- University of Management & Technology
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Age 40-60 years Both genders male and female Patient have diagnosed OA severity of (Kellgren Lawrence) Grade I-II knee OA. Patients able to walk independently without assistive device. Knee pain ≥ 3 months. Pain intensity score is 3-6 out of 10 on numeric rating scale. Have unilateral or bilateral knee OA.
Exclusion Criteria:
History of total knee replacement surgery. Inflammatory disorders. Severe visual or hearing impairment.(36) Severe cardiovascular disorders (such as Myocardial infarction) Neurological disorders (e.g., stroke, Parkinson's disease). History of deep vein thrombosis (DVT) and chronic kidney disease. Lower limb fracture.
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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Experimental: Dual task training
Participants will receive dual-task training involving simultaneous performance of motor and cognitive tasks alongside conventional physiotherapy. The intervention will include functional activities such as walking, standing, and sit-to-stand while performing cognitive tasks, including counting backward, verbal fluency, or responding to simple questions. Task difficulty will be progressively increased according to participants' abilities and tolerance to improve balance, functional mobility, and cognitive-motor coordination. |
Participants will receive dual-task training involving simultaneous performance of motor and cognitive tasks alongside conventional physiotherapy. The intervention will include functional activities such as walking, standing, and sit-to-stand while performing cognitive tasks, including counting backward, verbal fluency, or responding to simple questions. Task difficulty will be progressively increased according to participants' abilities and tolerance to improve balance, functional mobility, and cognitive-motor coordination. The intervention will be performed three times per week for six weeks. |
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Aktiver Komparator: Rhythmic stabilization
Participants will receive rhythmic stabilization based on proprioceptive neuromuscular facilitation (PNF) principles, targeting the knee joint in supine, sitting, and standing positions. The technique involves applying alternating manual resistance in multiple directions while participants maintain isometric contractions without allowing joint movement. Participants will be instructed to resist the therapist's forces to facilitate muscle co-contraction, improve knee stability, neuromuscular control, and balance. |
Participants will receive rhythmic stabilization based on proprioceptive neuromuscular facilitation (PNF) principles, targeting the knee joint in supine, sitting, and standing positions. The technique involves applying alternating manual resistance in multiple directions while participants maintain isometric contractions without allowing joint movement. Participants will be instructed to resist the therapist's forces to facilitate muscle co-contraction, improve knee stability, neuromuscular control, and balance. The intervention will be performed three times per week for six weeks, alongside conventional physiotherapy. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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NPRS
Zeitfenster: Baseline and after 6 weeks
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11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADL |
Baseline and after 6 weeks
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Berg Balance Scale
Zeitfenster: Baseline and after 6 weeks
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The Berg Balance Scale (BBS) will be used to assess functional balance in patients with knee osteoarthritis. It is a standardized 14-item scale that evaluates balance during daily functional activities such as sitting, standing, turning, reaching, transferring, and single-leg standing. Each item is scored on a 4-point Likert scale, with a total score ranging from 0 to 56, where higher scores indicate better balance performance. Scores of 0-20 indicate high fall risk, 21-40 indicate moderate fall risk, and scores ≥41 indicate low fall risk. The BBS is a highly reliable and valid tool for assessing balance in individuals with knee OA |
Baseline and after 6 weeks
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Joint position Sense Error
Zeitfenster: Baseline and after 6 weeks
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Joint Position Error (JPSE) will be assessed using Smartphone Inclinometer to evaluate proprioception. The participant's limb will be passively positioned at a target angle (e.g., 30° knee flexion) with eyes closed, and then returned to the starting position. The participant will then actively reproduce the same angle, and the smartphone Inclinometer will record the difference between the target and reproduced angle. This difference, measured in degrees, represents the JPSE. Smaller error values indicate better proprioceptive accuracy and joint position sense. |
Baseline and after 6 weeks
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Western Ontario and McMaster Universities Osteoarthritis Index:
Zeitfenster: Baseline and after 6 weeks
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The WOMAC is a valid, reliable, and widely used disease-specific outcome measure for assessing pain, stiffness, and physical function in individuals with knee osteoarthritis. It comprises 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is rated on a 5-point Likert scale ranging from 0 (none) to 4 (extreme). The total score is calculated by summing the responses, with higher scores indicating greater pain, stiffness, and functional impairment |
Baseline and after 6 weeks
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Mitarbeiter und Ermittler
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Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
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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
Andere Studien-ID-Nummern
- RE-180-2026
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
The results data collected , de-identified individual participant data will be shared.
IPD-Sharing-Zeitrahmen
6 months after the publication of the manuscript
IPD-Sharing-Zugriffskriterien
The data can be requested from the corresponding author
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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