Effectiveness of electrical muscle stimulation combined with treadmill training on Gait and Balance improvement in Stroke patients-A Randomized Controlled Trial

NEED FOR THE STUDY

Stroke patients generally have impairments such as motor, sensory, emotional, and cognitive dysfunction as well as functional restrictions. As a result of stroke, muscle tension increases abnormally, resulting abnormality in upper and lower limb that makes it difficult to perform walking ability in day to day life. Difficulty in walking appears in 20% of stroke survivors and mainly impairs balance and gait. Around the globe, Stroke prevalence among the elderly in rural India was 1.1% and urban India was 1.9%. Current literature has shown that gait and balance impairment is one of the most common problems in Stroke patients. There are very few literatures available on conservative management to improve gait and balance in stroke patients. The Electrical Muscle Stimulation combined with treadmill training gives better effect in stroke patients. Hence the need of my study is Effectiveness of Electrical muscle stimulation combined with treadmill training on gait and balance improvement in stroke patients.

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RESEARCH QUESTION

Will there any Effect of Electrical muscle stimulation combined with treadmill training on gait and balance improvement in stroke patients?

AIM AND OBJECTIVES

 Aim:

Ø  To study the effect of Electrical muscle stimulation combined with treadmill training on gait and balance improvement in stroke patients.

Objectives:

Ø  To study the effect of Electrical muscle stimulation combined with Treadmill on gait improvement in stroke patients by Dynamic gait index, Functional Ambulation Category, time up and go and gait assessment.

Ø  To study the effect of Electrical muscle stimulation combined with Treadmill training on balance improvement in stroke patients by Berg balance scale.

 Hypotheses

Null Hypothesis (H0):

There will be no significant effect of Electrical muscle stimulation combined with treadmill training on gait improvement in stroke patients.

Alternative Hypothesis (H1):

There will be significant effect of Electrical muscle stimulation combined with treadmill training on gait improvement in stroke patients.

METHODOLOGY

7.1 Source of Data: Pravara Rural Hospital, Loni.

Study Setting: The study will be conducted at department of Neuro-Physiotherapy,  Dr. A.P.J. Abdul Kalam College of Physiotherapy, PIMS, Loni

 7.2 Method of collection of data: Data will be collected by primary investigator

Type of Data:  Quantitative

**Study Design:**Randomized Controlled Trial

Sample size:

Participants:  Patients with stroke

Sampling Method: Simple Random Sampling

Study Duration: 2 years

Material to be used:

Ø  Data Record Sheet

Ø  Assessment sheet

Ø  Consent Form

Ø  Pen

Ø  Electrical Muscle Stimulation

Ø  Treadmill

Ø  Measuring tap

SELECTION CRITERIA:

Inclusion criteria:

Participants included will be:

Ø  Patients with 30–65 years of age

Ø  Male and female can equally participate

Ø  Subject diagnosed as stroke.

Ø  Ability to walk without any support for at least 10 m

Ø  Ambulation ability ≥3 based on functional ambulation classification

Ø  Patients with unilateral Hemiplegia

Ø  Participants willing to participate

 E****xclusion criteria:

Participants excluded will be:

Ø  Unconscious patients

Ø  Patients with psychiatric disorder

Ø  Patients with recurrent stroke

Ø  Patients with metabolic disorder

Ø  contractures of the lower extremities

Ø  metallic implants in the legs

OUTCOME MEASURES

Outcome measures used for this study will be as follows,

 

Variable

Method of Measurement

Statistical Scale

Descriptive Statistics

|Age

Interview

Nominal scale

Mean ± SD Proportion

|Gender

Observation

Nominal scale

Mean ± SD Proportion

|Gait

Ø  Dynamic gait index,

Ø  Functional Ambulation Category,

Ø  Time Up and Go and

Ø  Gait assessment.

 Ordinal scale

Mean ± SD Proportion

|Balance

Ø  Berg balance scale

Ordinal scale

Mean ± SD Proportion

  1. Dynamic gait index: The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24

2. Functional Ambulation Category : The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device The FAC is a quick visual measurement of walking, is simple to use, easy to interpret, and cost-effective because only stairs and 15m of indoor floor are needed to administer the test Scoring of FAC is 0-Nonfunctional ambulato,1-Ambulator, dependent on physical assistance – level I,2-Ambulator, dependent on physical assistance – level II,3-Ambulator, dependent on supervision,4-Ambulator, independent level surface only,5-Ambulator, independent

 3.Timed Up and Go: The reliability of the TUG (intraclass correlation coefficient [ICC2,1] = 0.98), DGI (ICC2,1 = 0.98) and BBS (ICC2,1 = 0.99) were excellent. The standard error of measurement (SEM) of the TUG, DGI, and BBS were 1.16, 0.71, and 0.98, respectively. The minimal detectable change (MDC) of the TUG, DGI, and BBS were 3.2, 1.9, and 2.7, respectively. There was a significant correlation found between the DGI and BBS (first reading [r] = 0.75; second reading [r] = 0.77), TUG and BBS (first reading [r] = −.52; second reading [r] = −.53), and the TUG and DGI (first reading [r] = 0.45; second reading [r] = 0.48), respectively.

4. Gait assessment: In gait assessment there are some parameters are taken Stride- The sequence of events between successive heel strike of the same foot, Step- The sequence of event between successive heel strikes of the opposite feet, Stride length- distance between two successive heel strikes of the same foot (144cm or 57 inches), Step length- distance between heel strike of two different feet (72cm or 8 inches),  Step width- lateral distance between heel centers of two consecutive foot contact (8 to 12 cm or 3 to 4 inches), Cadence- Number of steps per minute (90 to 120 steps/ min),  Stride time- time for full gait cycle, Step time- Time for completion of heel strike of right foot to heel strike of left foot.

5. The Berg Balance Scale (BBS)- The Berg Balance Scale(BBS) is used to objectively determine a patient’s ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It is use for elderly population with balance impairments, patients with acute stroke.

 PROCEDURE

·       Protocol will be prepared and ethical clearance will be obtained from the IEC.

·       The Participants will be selected based on the inclusion and exclusion criteria for eligibility.

·       Informed consent will be obtained from the participants and demographic data is recorded.

·       41 Participants will be randomly allocated to 2 groups that is experimental group(n=21) and control group(n=20). Prior assessment of the participants will be done.

·       Experimental group will be administered with Electrical muscle stimulation combined with treadmill training for stroke patients and control group will be administered with conventional exercise program for Stroke patients.

·       All the instructions will be given verbally, provided demonstration to the participants.

·       The participants will be given exercise regimen and administered to perform one session per day for 4 days in a week for 6 weeks.

·       The variables like Dynamic gait index, Functional ambulatory category, up and go test, gait assessment and berg balance scale will be measured accordingly.

·       Statistical analysis will be done and the results with the conclusion will be mentioned.