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Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop

Primary Purpose

Foot Drop

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Faradic current
Ankle foot orthosis
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Drop focused on measuring Stroke, Faradic Current, Ankle-Foot Orthosis, Foot Drop, Randomized Control Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who had been affected by stroke
  2. Good communication skills so the patient can follow the instructions
  3. Patients of both genders with any age group

Exclusion Criteria:

1 Impairment in lower limb other that foot drop 2. Patient suffering with any cardiovascular disease

Sites / Locations

  • Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Faradic current

Ankle foot orthosis

Arm Description

This study will use the faradic current for treating foot drop. In Group A 15 number of patient with foot drop will get the 40 minutes of session with the frequency of 50-100hz alternative three days / week for 25 weeks

Group B will get the treatment by Ankle foot orthosis.In group B 15 patients with foot drop will get the session alternative three days/week for 25 weeks. All participants have to use Ankle foot orthosis on a daily basis and patients have to walk for 10 minutes without walking aid.

Outcomes

Primary Outcome Measures

Berg Balance Scale
The Berg Balance Scale is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks.
Stroke impact scale
The Stroke Impact Scale assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function. *The first four of these domains may be combined into one physical domain, but the others must be scored separately.

Secondary Outcome Measures

Full Information

First Posted
July 4, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05449275
Brief Title
Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop
Official Title
The Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop Due To Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research aims to compare changes in gait quality and function between faradic current & Ankle foot orthosis with stroke related foot drop
Detailed Description
Randomized control trial study will be carried out at different health care units when synopsis will be approved. Enrollment of patients will be done by using purposive sampling technique. The selection of the patients will be done on the basis of exclusion criteria and inclusion criteria. The patients enrolled will be divided into 2 groups. Group A patients will be given faradic current on the other hand group B patients will be provided with ankle foot orthosis. The assessment of the patient will be done after 6 months and the outcome tools used will be 10-meter walk test, stroke impact scale, 6-meter walk test, Berg balance scale, Time up and go test. The data of the patient will be noted before giving treatment and after treatment and will be compared after 6 months. Consent will be taken from each patient. Statistical Package of Social Sciences Version 20 will be used for the entry and analysis of data

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Drop
Keywords
Stroke, Faradic Current, Ankle-Foot Orthosis, Foot Drop, Randomized Control Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Faradic current
Arm Type
Experimental
Arm Description
This study will use the faradic current for treating foot drop. In Group A 15 number of patient with foot drop will get the 40 minutes of session with the frequency of 50-100hz alternative three days / week for 25 weeks
Arm Title
Ankle foot orthosis
Arm Type
Experimental
Arm Description
Group B will get the treatment by Ankle foot orthosis.In group B 15 patients with foot drop will get the session alternative three days/week for 25 weeks. All participants have to use Ankle foot orthosis on a daily basis and patients have to walk for 10 minutes without walking aid.
Intervention Type
Other
Intervention Name(s)
Faradic current
Intervention Description
The most common Electrical stimulation applied for foot drop is faradic current. Faradic current provides the strength and improvement to volitational muscles and increase the coordination and reduce spasticity.
Intervention Type
Other
Intervention Name(s)
Ankle foot orthosis
Intervention Description
AFO is most commonly used technique but it also has some disadvantage mainly is the movement in limited direction and also in development of contractures and may have the problem in standing from chair
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
The Berg Balance Scale is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks.
Time Frame
12th Week
Title
Stroke impact scale
Description
The Stroke Impact Scale assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function. *The first four of these domains may be combined into one physical domain, but the others must be scored separately.
Time Frame
12th Week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had been affected by stroke Good communication skills so the patient can follow the instructions Patients of both genders with any age group Exclusion Criteria: Impairment in lower limb other that foot drop Patient suffering with any cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop

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