AmputationNCT06830876
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
A study testing Chattanooga Continuum Device in people with Amputation, run by Sara Peterson-Snyder at 1 site in United States.
Trial summary
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Chattanooga Continuum Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Have a unilateral transtibial amputation
- Have normal sound limb range of motion and function
- Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads
- Report current pain at a level 3 or higher on a Visual Analog Scale (VAS)
- Pass a monofilament test on the residual limb in 7 out of 10 areas to ensure adequate sensation for NMES stimulation
- Have a body mass index (BMI) of 35 kg/cm2 or less as NMES works more effectively on lower BMI
Who cannot join
- Have used electrical stimulation on the residual limb in the past six months
- Have been diagnosed as a severe diabetic or self-report insensate skin
- Have the presence of open wounds/ulcers on the residual limb
- Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb
- Wear a pacemaker or implanted cardiac defibrillator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyle Leister, PhD contact
United States1 site, 1 recruiting
- Recruiting
Cranberry Township Building
Pittsburgh, Pennsylvania, 16066
Sara L. Peterson, PhD, 4127363131, sara@opclinicalinnovations.com
Kyle Leister, PhD
About this study
Official title: Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users.
Amputees commonly experience muscle deficits leading to mobility issues, poor prosthetic fit, and chronic pain. Neuromuscular electrical stimulation (NMES) is a potential intervention that activates muscles with low-level electrical stimulation, improving strength, function, and reducing pain. The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees.
Twenty participants with transtibial amputations will undergo an 8-week NMES training program. Ultrasound imaging will assess muscle thickness, cross-sectional area, and composition changes. The study aims to enhance mobility, prosthetic fit, and overall well-being of amputees, addressing challenges and reducing healthcare burdens.
Read the detailed description
This study investigates the efficacy of a home-based Neuromuscular Electrical Stimulation (NMES) intervention in improving muscle parameters, reducing pain, and enhancing gait biomechanics in individuals with unilateral transtibial amputation (TTA). Muscle atrophy and sarcopenia, common in individuals with amputations, result in reduced muscle strength, volume, and functional impairments. The NMES intervention aims to counter these deficits by promoting muscle hypertrophy and improving residual limb muscle quality.
Ultrasound (US) imaging, a safe and non-invasive technique, will be used to assess muscle composition and quality, focusing on muscle thickness (MT), cross-sectional area (CSA), and muscle fat infiltration (MFI) of key muscle groups, including the vastus medialis oblique (VMO), tibialis anterior (TA), and gastrocnemius (GM) muscles. Baseline measures will be compared to post-NMES intervention data to evaluate changes in muscle parameters.
Participants will undergo an 8-week NMES program using a portable device. Electrode placement and settings will be customized to target specific muscle groups for optimal stimulation and contraction. Anthropometric measurements, gait analysis, and self-reported pain levels will be collected at baseline, midpoint, and post-intervention. The study will utilize US imaging to validate changes in muscle composition and quality and examine improvements in gait parameters such as stride length, velocity, and step symmetry using the GAITRite® system.
This project is a critical step in addressing the lack of standardized rehabilitation protocols for individuals with TTA. By leveraging NMES and US imaging, the study aims to develop a cost-effective, accessible intervention that enhances prosthetic fit, stabilizes limb volume, and improves mobility. The findings will contribute to refining rehabilitation strategies and improving the quality of life for individuals with limb loss.
- Conditions
- Amputation
- Being tested
- Chattanooga Continuum Device
- Keywords
- residual limb, pain, gait
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chattanooga Continuum DeviceDevice
Also called Continuum Device (EMPI)
The Chattanooga Continuum (Enovis, Wilmington, DE) is an FDA-approved, multi-functional, dual-channel electrotherapy device that offers adjunctive rehabilitation therapies, including muscle re-education (NMES), pain control, and stimulation of local blood circulation. The device provides a treatment duration of up to 60 minutes, allowing for cycled or continuous therapy. It offers symmetrical and asymmetrical waveform types, adjustable pulse rates of up to 150 Hz, and pulse width durations of up to 400 μs. The device also features off times, channel ramp times, and on time settings. Additionally, the Continuum is equipped with a data and parameter logger, enabling the monitoring of patient usage. It incorporates an automatic lock function to prevent accidental changes in intensity by preventing unintended pressing of the control buttons. The device operates on two AA rechargeable NiMH batteries, and a battery charger and extra batteries are included with the device.
| Study group | Role | What they receive |
|---|---|---|
| NMES | Other | All participants will undergo an 8-week Neuromuscular Electrical Stimulation (NMES) intervention using a portable NMES device at home. Participants will use the device on their residual limb to stimulate specific muscle groups (vastus medialis oblique, tibialis anterior, and gastrocnemius muscles). Electrode placement, stimulation intensity, and session frequency will be standardized and tailored to each participant to achieve strong but tolerable muscle contractions. Receives: Device: Chattanooga Continuum Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine changes in muscle thickness changes via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Compared to baseline, amputees' residual limb will show changes in Muscle Thickness (MT) measured in centimeters (cm) of the vastus medialis oblique (VMO), Tibialis Anterior (TA) and gastrocnemius muscles (GM) post-NMES intervention.
Measured: 9 months
Secondary outcomes (8)
To determine changes in muscle cross-sectional area (CSA) via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Compared to baseline, amputees' residual limb will show changes in Muscle Cross-sectional area (CSA) measured in centimeters (cm) post-NMES intervention.
Measured: 9 months
To determine changes in Muscle Fat Infiltration (MFI) or myosteatosis via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Compared to baseline, amputees' residual limb will show changes in Muscle Fat Infiltration (MFI) or myosteatosis post-NMES intervention using values between 0 and 255 (0: black; 255: white) and scored with the Modified Heckmatt scale as z-scores.
Measured: 9 months
To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in chronic residual limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Measured: 9 months
To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in phantom limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Measured: 9 months
To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in phantom sensation after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Measured: 9 months
To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait parameters of step length in meters (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Measured: 9 months
To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait parameters of step width in meters of the amputated side (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Measured: 9 months
To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait velocity (meters/time) after (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start10 Dec 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study, with a one-group, repeated measures experiment with individuals with unilateral transtibial limb loss (n=20) who are independent ambulators. A repeated measures design is chosen to gather additional data efficiently, using the unaffected side as the control.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Peterson-Snyder
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Sara Peterson-Snyder, O&P Clinical Innovations
- Investigators
- Kyle Leister, PhD, Principal investigator, East Tennessee Sate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830876
- Sponsor's protocol ID
- NMES-PIT-24
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36.
PubMed 1874764Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.
PubMed 12858461
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation
- ClinicalTrials.gov ID
- NCT06830876
- Acronym / sponsor ID
- NMES-PIT-24
- Conditions
- Amputation
- Keywords
- residual limb, pain, gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sara Peterson-SnyderIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users.
Amputees commonly experience muscle deficits leading to mobility issues, poor prosthetic fit, and chronic pain. Neuromuscular electrical stimulation (NMES) is a potential intervention that activates muscles with low-level electrical stimulation, improving strength, function, and reducing pain. The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees.
Twenty participants with transtibial amputations will undergo an 8-week NMES training program. Ultrasound imaging will assess muscle thickness, cross-sectional area, and composition changes. The study aims to enhance mobility, prosthetic fit, and overall well-being of amputees, addressing challenges and reducing healthcare burdens.
Detailed description
This study investigates the efficacy of a home-based Neuromuscular Electrical Stimulation (NMES) intervention in improving muscle parameters, reducing pain, and enhancing gait biomechanics in individuals with unilateral transtibial amputation (TTA). Muscle atrophy and sarcopenia, common in individuals with amputations, result in reduced muscle strength, volume, and functional impairments. The NMES intervention aims to counter these deficits by promoting muscle hypertrophy and improving residual limb muscle quality.
Ultrasound (US) imaging, a safe and non-invasive technique, will be used to assess muscle composition and quality, focusing on muscle thickness (MT), cross-sectional area (CSA), and muscle fat infiltration (MFI) of key muscle groups, including the vastus medialis oblique (VMO), tibialis anterior (TA), and gastrocnemius (GM) muscles. Baseline measures will be compared to post-NMES intervention data to evaluate changes in muscle parameters.
Participants will undergo an 8-week NMES program using a portable device. Electrode placement and settings will be customized to target specific muscle groups for optimal stimulation and contraction. Anthropometric measurements, gait analysis, and self-reported pain levels will be collected at baseline, midpoint, and post-intervention. The study will utilize US imaging to validate changes in muscle composition and quality and examine improvements in gait parameters such as stride length, velocity, and step symmetry using the GAITRite® system.
This project is a critical step in addressing the lack of standardized rehabilitation protocols for individuals with TTA. By leveraging NMES and US imaging, the study aims to develop a cost-effective, accessible intervention that enhances prosthetic fit, stabilizes limb volume, and improves mobility. The findings will contribute to refining rehabilitation strategies and improving the quality of life for individuals with limb loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study, with a one-group, repeated measures experiment with individuals with unilateral transtibial limb loss (n=20) who are independent ambulators. A repeated measures design is chosen to gather additional data efficiently, using the unaffected side as the control.
| Arm | Type | Receives |
|---|---|---|
| NMES | Other | Device: Chattanooga Continuum DeviceAll participants will undergo an 8-week Neuromuscular Electrical Stimulation (NMES) intervention using a portable NMES device at home. Participants will use the device on their residual limb to stimulate specific muscle groups (vastus medialis oblique, tibialis anterior, and gastrocnemius muscles). Electrode placement, stimulation intensity, and session frequency will be standardized and tailored to each participant to achieve strong but tolerable muscle contractions. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Have a unilateral transtibial amputation
- Have normal sound limb range of motion and function
- Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads
- Report current pain at a level 3 or higher on a Visual Analog Scale (VAS)
Key exclusion criteria (5 listed)
- Have used electrical stimulation on the residual limb in the past six months
- Have been diagnosed as a severe diabetic or self-report insensate skin
- Have the presence of open wounds/ulcers on the residual limb
- Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb
- Wear a pacemaker or implanted cardiac defibrillator
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 |
|---|---|---|
| Chattanooga Continuum DeviceAlso: Continuum Device (EMPI)The Chattanooga Continuum (Enovis, Wilmington, DE) is an FDA-approved, multi-functional, dual-channel electrotherapy device that offers adjunctive rehabilitation therapies, including muscle re-education (NMES), pain control, and stimulation of local blood circulation. The device provides a treatment duration of up to 60 minutes, allowing for cycled or continuous therapy. It offers symmetrical and asymmetrical waveform types, adjustable pulse rates of up to 150 Hz, and pulse width durations of up to 400 μs. The device also features off times, channel ramp times, and on time settings. Additionally, the Continuum is equipped with a data and parameter logger, enabling the monitoring of patient usage. It incorporates an automatic lock function to prevent accidental changes in intensity by preventing unintended pressing of the control buttons. The device operates on two AA rechargeable NiMH batteries, and a battery charger and extra batteries are included with the device. | Device | NMES |
Primary outcome
To determine changes in muscle thickness changes via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Time frame: 9 months
Compared to baseline, amputees' residual limb will show changes in Muscle Thickness (MT) measured in centimeters (cm) of the vastus medialis oblique (VMO), Tibialis Anterior (TA) and gastrocnemius muscles (GM) post-NMES intervention.
8 secondary outcomes
To determine changes in muscle cross-sectional area (CSA) via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Time frame: 9 months
To determine changes in Muscle Fat Infiltration (MFI) or myosteatosis via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Time frame: 9 months
To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.
Time frame: 9 months
To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.
Time frame: 9 months
To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.
Time frame: 9 months
To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.
Time frame: 9 months
To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.
Time frame: 9 months
To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 1874764Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36.
- Background: PubMed 12858461Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.
- Individual participant dataSharing planned: Undecided
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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.
Kyle Leister, PhD contact
Kyle Leister, PhD principal investigator
East Tennessee Sate 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 Chattanooga Continuum Device in people with Amputation, run by Sara Peterson-Snyder 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Peterson-Snyder, PhD (4127363131, sara@opclinicalinnovations.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine changes in muscle thickness changes via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830876, which also lists 2 linked publications.
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 17 Feb 2025.