Effectiveness of integrating Functional electrical stimulation with Task oriented training in improving the upper limb function in individuals with spinal cord injury
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
-
Age 18 to 60 years
-
Level of injury C5 to C7
3.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
EXCLUSION CRITERIA
- 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
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
SHELLY SHARMA
Indian Spinal Injuries Centre-Institute of Rehabilitation Sciences
