CTRI/2024/04/065570尚未招募不适用
Comparing the benefits of a customisable manual wheelchair, power-assist for wheelchairs and a standard manual wheel chair on everyday activities of female wheelchair users – A Randomised Controlled Trial
TTK Center for Rehabilitation Research and Device Development1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年4月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reintegration to Normal Living Index (RNLI)
研究概览
简要总结
The study on female wheelchair users will provide 2 types of wheelchairs to 2 groups of participants - A customised manual wheelchair and a power assisted wheelchair respectively. The effect of these 2 wheelchairs on daily activities will be compared to participants using a standard manual wheelchair. The data will be analysed to assess the impact of the 3 different wheelchairs on productivity and leisure of female wheelchair users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Female participants with spinal cord injury (complete and incomplete) between C
- •T12 level, lower-limb amputation who use wheelchairs, Stroke.
- •Paraparesis presentation Post Polio Residual Syndrome Cerebral Palsy
- •Participants living within 30kms of trained wheelchair prescription professionals
- •Experienced wheelchair users with at least 6 months of usage
- •35 to 110 kg
- •145 to 180 cm
- •33 cm to 16 cm
- •Sitting balance.
- •Range of Motion.
- •At least 90 degrees of hip and knee flexion. Up to 5 degrees of ankle plantarflexion.
- •Complete, active range of motion of shoulder, elbow and wrist joints
- •Hand function – Fair.
排除标准
- •Skin injuries.
- •Grade 2, 3 or 4 over the sacrum, ischium, greater trochanter, lesser trochanter, coccyx, calcaneum, popliteal fossa, olecranon process and anywhere in the entire posterior surface of thigh, from ischial tuberosity to popliteal fossa
- •Involuntary movements in lower limbs and trunk strong enough to disturb sitting balance.
- •Spasticity in any muscle group of upper and lower limb greater than grade 3 on Modified Ashworth Scale
- •Fixed Pelvic obliquity
- •Fixed Scoliosis
- •Fixed Kyphosis
- •Postural Hypotension
- •Unhealed musculoskeletal injuries or deformities such as unhealed fractures, heterotopic ossification, myositis ossificans
- •Affected higher mental functions
- •Hemiplegia or Hemiparesis.
结局指标
主要结局
Reintegration to Normal Living Index (RNLI)
时间窗: Will be administered at baseline (Week 0) and post-intervention (Week 5)
次要结局
- Self-Reported Questionnaire(Will be administered at baseline (Week 0) and post-intervention (Week 5))
研究者
Dr Sujatha Srinivasan
TTK Center for Rehabilitation Research and Device Development, IIT Madras
研究点 (1)
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