Gamified Sensor-Based Upper Extremity Functional Rehabilitation in Individuals with Spinal Cord Injury: A Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Graded Redefined Assessment of Strength Sensibility and Prehension GRASSP-II
研究概览
简要总结
This pilot clinical trial will investigate the feasibility and effectiveness of a gamified sensor-based rehabilitation protocol for improving upper extremity motor function in individuals with cervical spinal cord injury . It will be conducted at Sri Balaji Action Medical Institute, New Delhi, India. The study utilizes the PABLO system of Tyromotion company integrating motion sensors and interactive games to promote task specific training over a 5-week intervention period. Participants will be engaging in structured game based therapy designed to enhance upper limb functions using real-time feedback.The study adopts a one-group pretest-posttest design with 20 participants with ASIA AIS categories A to D with neurological level of injury from C4 to C8. Following outcome measures will be used to assess various outcomes such as GRASSP-II, SCIM-III, UEMS, CUE-Q, and ISCoS QOL dataset. Preliminary findings will assess user acceptability, clinical relevance, and functional improvement, laying the foundation for future controlled trials in neurorehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •At least 18 years of age(either male or female)
- •Either traumatic or non-traumatic SCI
- •Less than 12 months from the injury
- •Spinal cord Injury AIS grade A-D, NLI: C4-C8
- •Able to tolerate sitting position on a wheelchair for at least 30 mins.
- •Able to read and understand either the English or Hindi language.
排除标准
- •Moderate to severe spasticity at shoulder, elbow, wrist joints (MAS 2- 4)
- •Having psychiatric or other neurological disorders other than SCI
- •Have extensive fixed contractures in the upper limb of the target hand preventing use of the instrument
- •Head injuries causing cognitive or visual impairment
- •Unstable episodes of Autonomic Dysreflexia.
- •Had uncorrected vision, had pain in the affected upper limb restricting upper limb movement
- •Patients having pressure sores.
结局指标
主要结局
1. Graded Redefined Assessment of Strength Sensibility and Prehension GRASSP-II
时间窗: At baseline (T0) and post intervention at 5 weeks
Upper extremity motor function
时间窗: At baseline (T0) and post intervention at 5 weeks
2. Capabilities of Upper Extremity Questionnaire CUE-Q
时间窗: At baseline (T0) and post intervention at 5 weeks
3. International Standards for Neurological Classification of Spinal Cord Injury ISNCSCI(UEMS)
时间窗: At baseline (T0) and post intervention at 5 weeks
次要结局
- Functional Independence- Spinal Cord Independence Measure SCIM-III(Quality of Life-International spinal cord society (ISCoS) QOL basic dataset V 1.0)