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临床试验/NL-OMON49529
NL-OMON49529已完成不适用

Towards a smart and intuitive controlled MyLeg prosthesis: acquisition of intramuscular electromyography for motion intention detection. A pilot study. - MyLeg: motion intention detection based on intramuscular EMG and TMR

Revalidatiecentrum Het Roessingh0 个研究点目标入组 15 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Transfemoral amputees with targeted muscle reinnervation:
  • - Aged 18 or above.
  • - Unilateral transfemoral amputation.
  • - At least one year after osseointegration implant surgery.
  • - At least six months after TMR surgery and visible contractions (by
  • ultrasound) of the TMR sites.
  • - Functional level defined as Medicare Functional Classification Level K2 to K4:
  • o Level 2: The patient has the ability or potential for ambulation with the
  • ability to traverse low-level environmental barriers such as curbs, stairs, or
  • uneven surfaces. Typical of the limited community ambulator.
  • o Level 3: The patient has the ability or potential for ambulation with
  • variable cadence. Typical of the community ambulatory who has the ability to
  • traverse most environmental barriers and may have vocational, therapeutic, or
  • exercise activity that demands prosthetic utilization beyond simple locomotion.
  • o Level 4: The patient has the ability or potential for prosthetic ambulation
  • that exceeds basic ambulation skills, exhibiting high impact, stress, or energy
  • levels. Typical of the prosthetic demands of the child, active adult, or
  • - Able to perform low to moderate vigorous physical activity for a duration of
  • 1 hour including breaks.
  • Transfemoral amputees:
  • - Aged 18 or above.
  • - Unilateral transfemoral amputation.
  • - At least one year after osseointegration implant surgery.
  • - Functional level defined as Medicare Functional Classification Level K2 to K4
  • [12]; see description above.
  • - Able to perform low to moderate vigorous physical activity for a duration of
  • 1 hour including breaks.
  • Able-bodied:
  • - Aged 18 or above.
  • - Able to perform low to moderate vigorous physical activity for a duration of
  • 1 hour including breaks.

排除标准

  • Transfemoral amputees (with targeted muscle reinnervation):
  • - Not willing to consent to participate in the study.
  • - Other musculoskeletal problems influencing walking abilities.
  • - Stump problems: untreated skin conditions, wounds, infections, or problems
  • affecting walking ability.
  • - Taking coumarin-derivatives and having an INR > 3.0. (Subjects with an INR *
  • 3.0 or using NOACs will be included in the study, and informed about the
  • slightly increased bleeding risk.)
  • - Have had amputation because of infection and/or bad wound healing.
  • Able-bodied:
  • - Not willing to consent to participate in the study.
  • - Musculoskeletal problems influencing walking ability.
  • - Taking coumarin-derivatives and having an INR > 3.0. (Subjects with an INR *
  • 3.0 or using NOACs will be included in the study, and informed about the
  • slightly increased bleeding risk.)

研究者

发起方
Revalidatiecentrum Het Roessingh

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