- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07686952
Effect of Kinect Based Upper Extremity Exergaming on Trunk Control and Postural Stability in Stroke Patients
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study investigates the effectiveness of Kinect-based upper extremity exergaming in enhancing trunk control, postural stability, upper limb function, and quality of life among individuals recovering from stroke. Stroke remains one of the leading causes of long-term disability worldwide, contributing significantly to motor impairments and reduced independence in activities of daily living (ADLs). In Pakistan alone, the estimated annual incidence is approximately 250 per 100,000 people, with stroke-related disabilities severely impacting the quality of life in affected individuals. Among the various impairments observed post-stroke, trunk dysfunction and impaired postural control often go unnoticed in clinical practice, yet they play a crucial role in mobility, coordination, and overall functional performance.
The trunk musculature serves as a central stabilizing unit for coordinated upper and lower limb movement. After a stroke, damage to the motor cortex disrupts bilateral innervation to the trunk muscles, leading to reduced anticipatory control, asymmetric posture, delayed muscle activation, and compensatory movement patterns. These impairments, if unaddressed, can limit recovery of independent function and contribute to fall risk. Despite the importance of trunk control, most rehabilitation protocols continue to focus either on upper or lower limb recovery in isolation, neglecting the interdependence between trunk function and limb mobility. Furthermore, postural stability-a predictor of long-term functional independence-also suffers due to compromised core strength, sensory deficits, and neuromuscular incoordination after stroke.
Virtual reality (VR)-based rehabilitation has emerged as a promising tool to address these limitations by offering immersive, task-specific, and repetitive training that engages patients both physically and cognitively. Kinect-based exergaming, in particular, has gained popularity due to its cost-effectiveness, accessibility, and the ability to capture full-body movements without the need for wearable sensors. The Microsoft Xbox Kinect system allows users to interact with games through body motion, providing a novel form of therapy that can be customized to target specific joint movements and muscle groups. When used for upper extremity rehabilitation, many of these exergames indirectly stimulate trunk control through dynamic reaching, weight shifting, and balance-maintaining tasks, thus creating potential for cross-regional therapeutic effects.
The current study will employ a randomized controlled trial design to compare the outcomes of Kinect-based upper extremity exergaming with traditional task-oriented training. A total of 40 participants, aged 40 to 60 years and within three months post-stroke, will be recruited using purposive sampling from the Foundation University College of Physical Therapy and Fauji Foundation Hospital. Participants will be randomly allocated into two groups using a coin toss method. Group A will receive Kinect-based VR training involving specific upper limb exergames such as boxing, table tennis, volleyball, and bowling, while Group B will undergo structured task-oriented upper extremity training involving functional movements like reaching, grasping, and lifting. Both groups will receive additional conventional physiotherapy based on clinical need.
The intervention will span eight weeks, with participants attending three sessions per week, each lasting 30 to 45 minutes. Outcome assessments will be conducted at three time points baseline, week 4, and week 8 using validated tools: Trunk Impairment Scale (TIS) for trunk control, Postural Assessment Scale for Stroke Patients (PASS) and Modified Functional Reach Test (MFRT) for postural stability, Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Wolf Motor Function Test (WMFT) for upper limb function, and Stroke-Specific Quality of Life Scale (SS-QoL) for overall well-being.
Several studies provide the foundation for this research. Bessa et al. (2020) conducted a randomized controlled trial to evaluate the effect of exergame training on postural balance in chronic stroke patients. The study involved 42 participants and used games designed primarily for balance training. The results demonstrated significant improvement in postural control among the experimental group, affirming that interactive gaming environments can enhance dynamic stability. However, this study focused on lower-limb and core engagement and did not investigate cross-regional effects initiated by upper extremity movements, which my study aims to address.
Another relevant study by El-Kafy et al. (2021) explored the benefits of combining virtual reality-based therapy with conventional upper limb rehabilitation in stroke patients. The researchers observed substantial improvement in upper limb function among patients who received the combined treatment compared to those who underwent conventional therapy alone. The study, however, faced limitations due to small sample size and high dropout rates caused by the COVID-19 pandemic. Moreover, it did not evaluate outcomes related to trunk control or postural stability, leaving a gap in understanding the broader effects of VR interventions.
A third study by Khallaf (2020) investigated the impact of task-specific training on trunk control and balance in individuals with subacute stroke. This study highlighted that targeted trunk training can significantly improve sitting balance and posture; however, it did not examine whether improvements in upper limb activity could also translate into better trunk performance. It also excluded upper extremity assessment entirely, thereby underscoring the need for integrated protocols that examine cross-functional outcomes.
From these insights from these three studies, this research aims to explore whether upper extremity-focused VR training can stimulate improvements beyond the limb itself-particularly in trunk control and postural stability. Kinect-based training requires patients to maintain upright posture, shift weight dynamically, and reach across their base of support, thus activating the core muscles responsible for balance and trunk alignment. Over time, such repetitive and interactive movements may enhance both anticipatory and reactive postural control, which are essential for functional independence.
This study aims to fill a critical gap in stroke rehabilitation research by assessing whether engaging and affordable technologies like Kinect can deliver not only targeted upper limb recovery but also broader benefits to trunk control and postural stability. If successful, the findings will support the integration of virtual reality-based interventions into standard clinical practice, especially in resource-constrained settings. This approach may lead to more holistic, motivating, and patient-centered rehabilitation strategies that significantly enhance the quality of life in stroke survivors.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Islamabad, Pákistán, 46000
- Foundation University College of Physical Therapy
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Sub acute and Chronic Stroke (>3 months)
- Both genders
- Age 40 years and above.
- Patient able to stand with eyes close for 10 seconds
- Patient able to understand commands
- TUG more than >20
- UL Fugyl Meyer Score (UL-FMS) < 30/66
Exclusion Criteria:
- Patient with history of active Fits and recurrent stroke attacks.
- Patients with neurological disorders other than stroke
- Patient with uncontrolled systemic disorders ( DVT, CABG, IHD, CHD, CPD, pacemaker use)
- Severe Musculoskeletal and orthopedic disorders.
- Patients diagnosed with Psychiatric disorder
- Pain in the hemiplegic shoulder NPRS >4
- Patients with diagnosed vestibular impairment
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Kinect-Based Upper Extremity Exergaming
Each session includes a 5-minute warm-up, 35 minutes of active gameplay (combination of selected exergames), and a 5-minute cool-down period.
Sessions occur three times per week for eight weeks, totaling 24 supervised sessions.
The complexity and intensity of the games are progressively adjusted based on the participant's functional ability.
Cuff weights (½ kg to 1 kg) are introduced from week 5 onwards to increase resistance and promote strength gains.
Participants progress through predefined game levels, beginning with basic motor tasks and advancing to more complex, multijoint coordination activities.
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The exergames include:
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Aktivní komparátor: Task oriented exercises
The training protocol is delivered three times per week for eight weeks, matching the frequency and duration of Arm A. Each session lasts 45 minutes, including a warm-up and rest periods.
Each task is repeated for 10-15 repetitions per set, with two sets per task, and modified based on the participant's ability and fatigue level.
From week 5 onwards, light cuff weights (½ to 1 kg) are incorporated to challenge muscle endurance and strength.
All exercises are demonstrated by the therapist before practice, and patients are encouraged to perform them with minimal compensation and maximal control.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Trunk control
Časové okno: 8 weeks
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Trunk Impairment Scale was used to measure trunk control.
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8 weeks
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Trunk Control
Časové okno: 8 weeks
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Modified Functional Reach test
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8 weeks
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Postural Stability
Časové okno: 8 weeks
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Postural Assessment Scale for Stroke Patients (PASS)
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8 weeks
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Upper Extremity function
Časové okno: 8 weeks
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Fugyl Meyer Scale (FMA -UE)
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8 weeks
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Upper Extremity function
Časové okno: 8 weeks
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Wolf Motor Function test
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8 weeks
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Quality of life of patients
Časové okno: 8 weeks
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Stroke-Specific Quality of Life Scale (SS-QoL) Scores range from 49 (worst) to 245 (best).
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8 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FUI/CTR/2025/06
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