Foot DropNCT05449275
Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop
A study testing Faradic current and Ankle foot orthosis in people with Foot Drop, run by Riphah International University at 1 site in Pakistan.
Trial summary
This research aims to compare changes in gait quality and function between faradic current \& Ankle foot orthosis with stroke related foot drop Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foot Drop
- What is being tested?
- Faradic current and Ankle foot orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Impairment in lower limb other that foot drop
- Patient suffering with any cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: The Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop Due To Stroke
This research aims to compare changes in gait quality and function between faradic current \& Ankle foot orthosis with stroke related foot drop
Read the 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
- Conditions
- Foot Drop
- Being tested
- Faradic current, Ankle foot orthosis
- Keywords
- Stroke, Faradic Current, Ankle-Foot Orthosis, Foot Drop, Randomized Control Trial
- Medical subject headings
- Peroneal Neuropathies, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faradic currentOther
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.
Ankle foot orthosisOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Ankle foot orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Mar 2021
- Primary completion20 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DropStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449275
- Sponsor's protocol ID
- REC-FSD-00264
- Status last verified
- Dec 2022
- First submitted
- 4 Jul 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Faradic Current Versus Ankle-Foot Orthosis In Patients With Foot Drop Due To Stroke
- ClinicalTrials.gov ID
- NCT05449275
- Acronym / sponsor ID
- REC-FSD-00264
- Conditions
- Foot Drop
- Keywords
- Stroke, Faradic Current, Ankle-Foot Orthosis, Foot Drop, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faradic current | Experimental | Other: Faradic currentThis 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 |
| Ankle foot orthosis | Experimental | Other: Ankle foot orthosisGroup 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Impairment in lower limb other that foot drop
- Patient suffering with any cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faradic currentThe 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. | Other | Faradic current |
| Ankle foot orthosisAFO 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 | Other | Ankle foot orthosis |
Primary outcome
Berg Balance Scale
Time frame: 12th Week
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
Time frame: 12th Week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Foot Drop
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faradic current and Ankle foot orthosis in people with Foot Drop, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 12th Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.