NCT05449275

Brief Summary

This research aims to compare changes in gait quality and function between faradic current \& Ankle foot orthosis with stroke related foot drop

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

July 4, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

StrokeFaradic CurrentAnkle-Foot OrthosisFoot DropRandomized Control Trial

Outcome Measures

Primary Outcomes (2)

  • 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.

    12th Week

  • 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.

    12th Week

Study Arms (2)

Faradic current

EXPERIMENTAL

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

Other: Faradic current

Ankle foot orthosis

EXPERIMENTAL

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.

Other: Ankle foot orthosis

Interventions

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.

Faradic current

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

Ankle foot orthosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Impairment in lower limb other that foot drop
  • Patient suffering with any cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Peroneal NeuropathiesStroke

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

March 1, 2021

Primary Completion

July 20, 2022

Study Completion

August 31, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations