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临床试验/NCT06259643
NCT06259643招募中不适用

Clinical and Psychosocial Impact of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Social participation

研究概览

简要总结

This study is a prospective interventional study. It will be conducted at a single center with participants who have neuromotor impairments. The primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion.

A maximum of twenty participants will be recruited and included in the same group. Data collection will be performed before, during, and after the wheelchair soccer season. The study will span the entire season, starting in November 2023 and ending in June 2024.

Clinical and psychosocial assessments will be conducted every 3 months. Each assessment session will last 2 hours per participant. Before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. These evaluations will last 10 minutes per participant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Being a male or female between the ages of 12 and
  • Presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment.
  • Using a power wheelchair in everyday life.
  • Being part of a power wheelchair soccer team.
  • Committing to participating in the 2023-2024 season of their sport within the team.

排除标准

  • Practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more).
  • Occasionally practicing power wheelchair soccer (twice a month or less).
  • Presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests.
  • Presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer.
  • Participating in another study at baseline.

结局指标

主要结局

Social participation

时间窗: Throughout the entire study (an average of 8 months)

Social participation will be assessed using the Questionnaire of young people's participation.Scores range from 0 to 239, where a higher score displays greater social participation.

Strength of the upper-limbs

时间窗: Throughout the entire study (an average of 8 months)

Strength of the main muscle groups of the upper-limb will be measured using a Microfet 2 dynamometer.

Passive range of motion the upper-limbs

时间窗: Throughout the entire study (an average of 8 months)

Passive range of motion of the upper-limbs will be measured using a goniometer.

Hyperactivity of the muscles

时间窗: Throughout the entire study (an average of 8 months)

Hyperactivity of the muscles will be measured using the Australian Spasticity Assessment scale of the upper-limb main muscle groups. Scores per muscle groups range from 0 to 4, where a higher score represents greater spasticity and more hyperactivity in the muscle group.

Sensorimotor impairment

时间窗: Throughout the entire study (an average of 8 months)

Sensorimotor impairment will be measured by the Fugl-Meyer assessment.

Quality of life

时间窗: Throughout the entire study (an average of 8 months)

Quality of life will be assessed using the KIDSCREEN 27 questionnaire. Scores range from 10 and 50, where 50 represents a very high health-related quality of life.

Autonomy during activities of daily life

时间窗: Throughout the entire study (an average of 8 months)

Autonomy during activities of daily life will be assessed using the Impact on participation and autonomy questionnaire. A participation score (range: 30-155) and a problem score (0-16) are produced by summing items in each scale. For both, a higher score represent poorer autonomy and more severe difficulty.

Pain

时间窗: Throughout the entire study (an average of 8 months)

Pain perceived by the participants in their daily life will be measured using the PROMIS pain-pediatric Short Form V2 questionnaire. Scores range from 8 to 40, where a higher score displays more pain in everyday life.

Skills to manage and move power wheelchair

时间窗: Throughout the entire study (an average of 8 months)

Skills to manage and move power wheelchair will be assessed by the Wheelchair Skills Test Questionnaire version 4.2. Scores range from 0 to 100%, where a greater percentage represents better skills.

Balance

时间窗: Throughout the entire study (an average of 8 months)

Balance will be measured using the Trunk control measurement scale. Scores range from 0 to 58, where a higher score displays better trunk control.

次要结局

  • Body temperature(Throughout the entire study (an average of 8 months))
  • Blood oxygen saturation(Throughout the entire study (an average of 8 months))
  • Heart beat rate(Throughout the entire study (an average of 8 months))
  • Blood pressure(Throughout the entire study (an average of 8 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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