跳至主要内容
临床试验/CTRI/2024/04/065570
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

发起方
TTK Center for Rehabilitation Research and Device Development
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Sujatha Srinivasan

TTK Center for Rehabilitation Research and Device Development, IIT Madras

研究点 (1)

Loading locations...

相似试验