跳至主要内容
临床试验/CTRI/2026/02/103545
CTRI/2026/02/103545尚未招募2/3 期

Effectiveness of integrating Functional electrical stimulation with Task oriented training in improving the upper limb function in individuals with spinal cord injury

Indian Spinal Injuries Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
24
试验地点
1

研究概览

简要总结

TITLE EFFECTIVENESS OF INTEGRATING FUNCTIONAL ELECTRICAL

STIMULATION WITH TASK ORIENTED TRAINING IN IMPROVING THE

UPPER LIMB FUNCTION IN INDIVIDUALS WITH SPINAL CORD INJURY

BACKGROUND

Spinal cord injury (SCI) frequently results in profound motor deficits, severely compromising

the well-being and daily functioning of individuals. The primary injury involves damage to

neural parenchyma, disruption of axonal networks, and disturbance of glial membranes,

halting transmission of signals from upper motor neurons to areas below the injury.

Functional Electrical Stimulation (FES) provides electrical pulses to stimulate motor neurons

and facilitate muscle contractions, while Task Oriented Training (TOT) emphasizes repetitive

practice of functional tasks. Although both interventions, FES and TOT have proven benefits

individually, their integrated application may enhance motor recovery by combining neural

activation with functional task practice. This study aims to evaluate the effectiveness of

integrating FES with TOT in improving fine and gross hand functions in individuals with

SCI.

OBJECTIVE

To determine the effect of integrating FES with task oriented training for hand functions in

individuals with spinal cord injury.

HYPOTHESIS:

NULL HYPOTHESIS-

H N There is no significant difference between the effects of integrating FES with task

oriented training on hand functions in individuals with spinal cord injury

ALTERNATE HYPOTHESIS-

H A There is significant difference between the effects of integrating FES with task oriented

training on hand functions in individuals with spinal cord injury

MATERIALS AND METHODS

STUDY DESIGN Experimental study design

SAMPLE SIZE 24 (12 in each group)

(Outcome measure used is Box and block test)

Song GB. The effects of task-oriented versus repetitive bilateral arm training on upper limb function and activities of daily

living in stroke patients.

ENROLMENT PERIOD 6-7 months after RRC and IEC clearance

INCLUSION CRITERIA

  1. Age 18 to 60 years

  2. Level of injury C5 to C7

3.Duration more than 3 months

  1. Individuals should have some level of

thumb and finger movements

  1. Able to tolerate being in a seated

position for a least 1 hour required to

deliver upper limb therapy

EXCLUSION CRITERIA

  1. Individuals who had contraindications for

FES, such as a cardiac pacemaker, skin

lesions, or a rash at a potential electrode

site

  1. Uncontrolled hypertension or autonomic

dysreflexia requiring medication

  1. History of seizure disorder not effectively

managed by seizure medications.

  1. Currently dependent on a ventilator

  2. Previous history of any other

neuromuscular disorder or conditions that

may affect motor response

TOTAL STUDY DURATION 4 weeks intervention duration.

STUDY PROCEDURES Patients will be screened based on inclusion and exclusion criteria.

They will be enrolled into 2 groups with the help of random allocation software.

Experimental Group A (FES+TOT) will receive Functional electrical stimulation and Task

oriented training, 5 times a week for 4 weeks. Experimental Group 2 (TOT+shams FES) will

receive task oriented training for the same duration.

ASSESSMENT TOOLS Pre- and post-intervention tests will be carried out using

Box and Block test (BBT)–to measure gross manual dexterity of

the upper limb.

Capabilities of Upper Extremity Questionnaire (CUE-Q) to assess

the functional use of upper limbs and covers gross and fine motor

skills.

STATISTICAL ANALYSIS PLAN (SAP):

Descriptive statistics will calculate the mean and standard deviation for quantitative

variables (e.g. age, BBT score) and frequencies for categorical variables (e.g.,

gender).

The Shapiro-Wilk test will assess normality.

If the data is normally distributed, an independent t-test will evaluate differences

between the groups.

Paired t-test will be used to evaluate average difference within the group for normal

data.

For skewed data, the Wilcoxon signed-rank test will assess within-group changes, and

the Mann-Whitney U test will compare between-group differences.

Data will be analysed using SPSS 21 with Excel for data management.

Statistical significance will be set at a 5% alpha level.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 60 years Level of injury C5 to C7 Duration more than 3 months Individuals should have some level of thumb and finger movements Able to tolerate being in a seated position for a least 1 hour required to deliver upper limb therapy.

排除标准

  • Individuals who had contraindications for FES, such as a cardiac pacemaker, skin lesions, or a rash at a potential electrode site Uncontrolled hypertension or autonomic dysreflexia requiring medication History of seizure disorder not effectively managed by seizure medications.
  • Currently dependent on a ventilator Previous history of any other neuromuscular disorder or conditions that may affect motor response.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SHELLY SHARMA

Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences

研究点 (1)

Loading locations...

相似试验