OsteoarthritisNCT05765435
A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
A study testing 12-week exercise and walking program, NMES and FES in people with Osteoarthritis and Osteoarthritis, Knee, run by Cionic, Inc. at 1 site in United States.
Trial summary
The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee
- What is being tested?
- 12-week exercise and walking program, NMES and FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2023to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with knee osteoarthritis between the ages of 22 and 75
- Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
- Able to tolerate the device for up to 1 hour per lab session
- No recent change in medication or exacerbation of symptoms over the last 60 days
- Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
- No hyaluronic acid or cortisone injection into knees in previous 12 months
Who cannot join
- Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
- Absent sensation in the impacted or more impacted leg
- Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
- Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
- Use of FES devices in the past year
- Demand-type cardiac pacemaker or defibrillator
Show all 14Show fewer
- Malignant tumor in the impacted or more impacted leg
- Existing thrombosis in the impacted or more impacted leg
- Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
- History of knee replacement surgery
- History of other types of arthritis
- History of neurological disease
- History of seizures or diagnosed with epilepsy/seizures
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis
The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). This study will use a home-based medical device to administer electrical stimulation and measure its effect on outcomes that include quadriceps strength, perceived functional capacity, pain, and walking performance. It was hypothesized that stimulation assisted activities will show larger muscle mass and strength improvements; improved gait kinematics, pain and perceived function; and a high compliance to the assigned program compared to no stimulation.
Read the detailed description
The study aims to evaluate the Cionic Neural Sleeve for subjects diagnosed with KOA. All participants will be assigned a Cionic Neural Sleeve to wear on the most impacted leg and be prescribed a home-based exercise and walking program. Participants will be randomly assigned into three groups: (a) control; (b) neuromuscular electrical stimulation (NMES); (c) NMES and functional electrical stimulation (FES). The control group will not receive stimulation for the exercise and walking program, whereas participants in the NMES group will receive stimulation during exercises, and participants in the NMES and FES group will receive stimulation during exercises and walking. The primary outcome measures include quadriceps strength and perceived pain. Exploratory outcome measures include adherence to the program, thigh muscle volume, functional ability of the lower limb, walking performance, perceived functional capacity, and perceived quality of life.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee
- Being tested
- 12-week exercise and walking program, NMES, FES
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week exercise and walking programOther
The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMESDevice
Also called External functional neuromuscular stimulator
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
FESDevice
Also called External functional neuromuscular stimulator
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation. Receives: Other: 12-week exercise and walking program |
| NMES | Experimental | Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions. Receives: Other: 12-week exercise and walking program; Device: NMES |
| NMES and FES | Experimental | Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions. Receives: Other: 12-week exercise and walking program; Device: NMES; Device: FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. Subjects performed 3 repetitions of maximal effort, separated by two minutes of rest between each. The average of the 3 repetitions was recorded as the subjects' 1 repetition maximum. A positive change indicates increased quadriceps strength.
Measured: Baseline, 6 weeks, 12 weeks
Change in Perceived Pain Scores From Baseline
Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire to measure perceived pain, measured by score. Scores on the WOMAC pain subscale range from 0 to 20, with high scores indicative of worse pain. A positive change indicates improvement.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start27 Jun 2023
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Why it stopped: Insufficient rate of accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cionic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Rebecca Webster, Cionic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765435
- Sponsor's protocol ID
- CIONIC-05-001
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2023
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05765435
- Acronym / sponsor ID
- CIONIC-05-001
- Conditions
- Osteoarthritis, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient rate of accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cionic, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). This study will use a home-based medical device to administer electrical stimulation and measure its effect on outcomes that include quadriceps strength, perceived functional capacity, pain, and walking performance. It was hypothesized that stimulation assisted activities will show larger muscle mass and strength improvements; improved gait kinematics, pain and perceived function; and a high compliance to the assigned program compared to no stimulation.
Detailed description
The study aims to evaluate the Cionic Neural Sleeve for subjects diagnosed with KOA. All participants will be assigned a Cionic Neural Sleeve to wear on the most impacted leg and be prescribed a home-based exercise and walking program. Participants will be randomly assigned into three groups: (a) control; (b) neuromuscular electrical stimulation (NMES); (c) NMES and functional electrical stimulation (FES). The control group will not receive stimulation for the exercise and walking program, whereas participants in the NMES group will receive stimulation during exercises, and participants in the NMES and FES group will receive stimulation during exercises and walking. The primary outcome measures include quadriceps strength and perceived pain. Exploratory outcome measures include adherence to the program, thigh muscle volume, functional ability of the lower limb, walking performance, perceived functional capacity, and perceived quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: 12-week exercise and walking programDevice: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation. |
| NMES | Experimental | Other: 12-week exercise and walking program, Device: NMESDevice: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions. |
| NMES and FES | Experimental | Other: 12-week exercise and walking program, Device: NMES, Device: FESDevice: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persons with knee osteoarthritis between the ages of 22 and 75
- Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
- Able to tolerate the device for up to 1 hour per lab session
- No recent change in medication or exacerbation of symptoms over the last 60 days
- Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
Key exclusion criteria (14 listed)
- Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
- Absent sensation in the impacted or more impacted leg
- Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
- Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
- Use of FES devices in the past year
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 |
|---|---|---|
| 12-week exercise and walking programThe exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day. | Other | Control, NMES, NMES and FES |
| NMESAlso: External functional neuromuscular stimulatorSleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times. | Device | NMES, NMES and FES |
| FESAlso: External functional neuromuscular stimulatorSleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times. | Device | NMES and FES |
Primary outcome
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. Subjects performed 3 repetitions of maximal effort, separated by two minutes of rest between each. The average of the 3 repetitions was recorded as the subjects' 1 repetition maximum. A positive change indicates increased quadriceps strength.
Change in Perceived Pain Scores From Baseline
Time frame: Baseline, 6 weeks, 12 weeks
Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire to measure perceived pain, measured by score. Scores on the WOMAC pain subscale range from 0 to 20, with high scores indicative of worse pain. A positive change indicates improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week exercise and walking program, NMES and FES in people with Osteoarthritis and Osteoarthritis, Knee, run by Cionic, Inc. at 1 site in United States.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Jul 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline (time frame: Baseline, 6 weeks, 12 weeks). 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 3 Jul 2025.