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临床试验/CTRI/2025/10/096141
CTRI/2025/10/096141尚未招募2/3 期

Effect of Transcranial Direct Current Stimulation augmented with Motor imagery on Upper Extremity Muscle Strength and Function in Spinal Cord Injury

未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月29日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Motor activity log scale- amount of use (MAL-AOU)

研究概览

简要总结

1.     **Title:**Effect of Transcranial Direct Current Stimulation augmented with Motor imagery on Upper Extremity Muscle Strength and Function in Spinal Cord Injury

Presenter’s Name: NADA ZAREEN, MPT (MUSCULOSKELETAL)

Guide: DR. MEGHA NIJHAWAN (ASSOCIATE PROFESSOR, ISIC-IRS)

Co-guide: DR. CHITRA KATARIA (PRINCIPAL, ISIC-IRS)

DR. MEENA MAKHIJA (ASSOCIATE PROFESSOR, ISIC-IRS)

2. Background:

Spinal cord injury (SCI) results from an insult inflicted upon the spinal cord that affects upper and lower limb  functions entirely or incompletely. Transcranial direct current stimulation (tDCS) has been proposed as a tool that helps enhance neural plasticity and also helps the brain reach a favorable state of excitability, accelerating motor learning and training effects.

Motor imagery (MI) -mentally rehearsing movements—activates motor-related brain regions (M1, SMA, parietal cortex) and it may facilitate motor recovery by promoting neural plasticity. While studies show MI improves motor function, it works best combined with other therapies such as tDCS.

Purpose of the trial is to find the combined effect of transcranial direct current stimulation along with motor imagery on upper limb muscle strength and function in spinal cord injury patients.

3. OBJECTIVES

To evaluate the effect of transcranial direct current stimulation augmented with motor imagery on Motor Activity Log- Amount Of Use (MAL-AOU), Upper Extremity Motor Score (UEMS), Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and Isometric Muscle strength (myometer) in individuals with spinal cord injury.

HYPOTHESIS

Null Hypothesis Ho-

•       There is no significant difference in the effect of transcranial direct current stimulation augmented with motor imagery and sham tDCS with Motor Imagery on Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use in individual with spinal cord injury.

Alternate Hypothesis H1-

•       There is a significant difference in the effect of transcranial direct current stimulation augmented with motor imagery and sham tDCS with Motor Imagery on Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use in individual with spinal cord injury.

 4. Material and Methods

 a.      Study Design: Randomized control study

 b.     Sample size and method:  A total of 20 participants (10 in each group). A prior sample size of 10 in each group is calculated from previous work by taking as the MAL AOU primary outcome with an effect size of 1.36, alpha = 0.05, power of test = 0.80. Total sample size = 20 (10 in each group).

  c.      Enrolment period: 3 months post injury

 d.     Total Study duration: Time duration will be about 5 to 6 months.

  e.    Inclusion and exclusion criteria: Eligible individuals will be aged 18–65 years, diagnosed with incomplete SCI and classified as B, C and D on the ASIA Impairment Scale (C4–C7 level), 3 months post injury. Any other pre-existing neurological problem, musculoskeletal condition, Psychiatric problem that may interfere with the treatment, Spasticity of grade three or more on the Modified Ashworth Scale, History of seizures or brain surgery, Metallic brain implant, Cardiac Pacemaker, Pregnancy will be excluded.

 f.      Study procedure: In each session you will be given tDCS and simultaneously you will practice a set of exercises mentally (Motor imagery) after that you have to physically perform the exercises.

 g.     Assessment tools:Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use.

 5.  Statistical Analysis Plan:

Data will be analysed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons. P value is less than 0.05.

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

  • Incomplete SCI and classified as B, C and D on the ASIA Impairment Scale
  • 3 months post injury
  • Level of injury – C4-C7
  • Traumatic and non traumatic SCI
  • Willing to participate.

排除标准

  • Any other pre-existing neurological problem, musculoskeletal condition, Psychiatric problem that may interfere with the treatment
  • Spasticity of grade three or more on the Modified Ashworth Scale
  • History of seizures or brain surgery
  • Metallic brain implant
  • Cardiac Pacemaker 6.

结局指标

主要结局

Motor activity log scale- amount of use (MAL-AOU)

时间窗: 03 weeks

次要结局

  • upper extremity motor scale (UEMS)(03 weeks)
  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)(03 weeks)
  • Isometric Muscle strength (myometer)(03 weeks)

研究者

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

Nada Zareen

Indian Spinal Injuries Centre- Institute of rehabilitation sciences

研究点 (1)

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