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临床试验/NCT04566809
NCT04566809已完成不适用

Cognitive Approach Using Functional Electric Stimulation for Grasp and Pinch Rehabilitation in Persons Affected by Cervical Spinal Cord Injury, a Randomized Controlled Trial

Azienda Ospedaliero, Universitaria Pisana0 个研究点目标入组 16 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Performance test: Bimanual Ability Test (BAT)

研究概览

简要总结

16 persons affected by Cervical-SCI were recruited for the study and randomly assigned to the Control Group (CG) or to the Experimental Group (EG). Persons of the CG (n = 8) executed 20 sessions of FES for the rehabilitation of hand functions (grasp or pinch), participants of the EG (n = 8) performed 20 sessions of FES and CBA in addition. The primary assessment was a modified version of Bimanual Activity Test (10 tasks); also, SCIM-II and measurement of grasping strength only in participants submitted to grasp rehabilitation were evaluated.

详细描述

Each participant followed twenty sessions of hand rehabilitation, three times per week. Each treatment, for both CG and EG, lasted about forty minutes.

The FES devices chosen for this research stimulated "grasp" or "pinch" function: the NESS H200 (NESS Ltd., Ra'anana, Israel) was used if patient needed to improve the grasp functions, otherwise the Microstim (Microstim, Medel, Hamburg, Germany) was used to increase pinch functions. In order to provide FES, the five electrodes of NESS H200 were first humidified with warm water and then inserted in the right size place of the rigid splint worn by the patient, while Microstim was used with four standard electrodes, two for each muscle treated. In both case the stimulation was triggered by the therapist clicking a button (Table 1).

The participants of CG received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices.

The participants of EG executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • C-SCI with neurological level between C2-T1;
  • reduced ability of hand functions;
  • excitable muscles and FES tolerability.

排除标准

  • any trauma or surgery to the target hand or upper limb within the last 12 months,
  • amputation of any digits on the target hand,
  • severe spasticity in the target hand or upper limb preventing use of the instruments,
  • experienced autonomic dysreflexia or hypotension in response to FES,
  • any contraindication to FES such as: cardiac pacemaker, epilepsy, forearm fracture, pregnancy, skin lesions, cancer or tumor, intracranial metal implants

结局指标

主要结局

Performance test: Bimanual Ability Test (BAT)

时间窗: 2 years

10 items evaluated, each one from 0 to 60 seconds. Less time needed means better skills

次要结局

  • Grasping Strength (GS)(2 years)
  • Spinal Cord Independence Measure (SCIM)(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Olivieri

Principal Investigator

Azienda Ospedaliero, Universitaria Pisana

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