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临床试验/CTRI/2024/11/076226
CTRI/2024/11/076226尚未招募2 期

Evaluation of synergistic effect of transcranial direct current stimulation with virtual reality assisted treadmill training for motor functions and quality of life of individuals with incomplete spinal cord injury : A Randomized controlled trail

未提供1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年11月12日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Strength: Lower extremity moto score (ASIA)

研究概览

简要总结

Background-Individuals with SCI possess significant challenges in motor function recovery. With those who able to achieve functional ambulation, they have impaired waking pattern, they tend to develop slow, inefficient unbalanced gait pattern with long cycle time and small strides. VR assisted treadmill training allows individual to correct their walking pattern through visual feedback. The training has been found effective in neurological population like stroke, multiple sclerosis, Parkinson’s disease etc. The growing body of research is emphasizing on the role of neuro-modulation including transcranial direct current simulation alone or in adjunct with other therapies. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation technique that has shown promise in various neurological conditions, including spinal cord injury (SCI). The application of tDCS involves delivering a low electrical current to specific areas of the brain through electrodes placed on the head. Recent evidence has explored the beneficial effects of transcranial stimulation on upper extremity functions and neuropathic pain among individuals with spinal cord injury. The application of transcranial direct current stimulation among spinal cord injury has shown mixed results for recovery of lower motor functions and ambulation. The available studies varies in session and location of the electrode placement. Moreover, there is dearth in literature that have combined innovative techniques.

Intervention: the 52 participants will be randomly assigned to intervention and sham group after baseline measurement . 20 minutes session for 15 times will be given and after 15 sessions post intervention measurements will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Traumatic and non- traumatic spinal cord injury.
  • Age 18 years to 65 years.
  • ASIA grade C and D.
  • Level of lesion T1 to L2
  • Functional ambulatory category more than or equal to
  • Who are able advance their leg on treadmill with 0.2 km/hour speed.
  • Atlest 3 months time since injury.

排除标准

  • Any other pre-existing neurological problem, musculoskeletal condition, cardiovascular or psychiatric problem which may interfere with the treatment.
  • 2.Spasticity of grade 3 or more in lower extremities on Modified Ashworth Scale which may interfere with the treatment.
  • 3.Visual or auditory impairment such that it impacts on the ability to participate.
  • 4.Body Weight more than 150 kg.
  • Skin lesions or rash at potential sites which may interfere with the treatment or placing of electrodes of transcranial direct current stimulation or Grade 2 or higher-pressure ulcers (according to the National Pressure Ulcer Advisory Panel classification) that interfered with harness support or walking or standing.
  • History of seizure, migraine, headache or epilepsy, brain surgery.
  • History of recent episode of orthostatic hypotension or autonomic dysreflexia.
  • 11.Previous experience of transcranial direct current stimulation or VR assisted treadmill training post SCI.

结局指标

主要结局

Strength: Lower extremity moto score (ASIA)

时间窗: At baseline and after 15 sessions

Balance: Functional reach test, Berg balance scale

时间窗: At baseline and after 15 sessions

Gait : WICII, Kinetic and kinemti parameters through walker view, 10m walk test

时间窗: At baseline and after 15 sessions

次要结局

  • Functional score: SCIM III(Quality of life: WHO-QOL BREF)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

DR GARIMA WADHWA PT

ISIC INSTITUTE OF REHABILITATION SCIENCES

研究点 (1)

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