Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2 (NCT NCT05200858)
NCT ID: NCT05200858
Last Updated: 2024-07-16
Results Overview
Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
baseline to 4 weeks
Results posted on
2024-07-16
Participant Flow
Participant milestones
| Measure |
Active Group (AG) Blinded Phase
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
Placebo Group (PG) Blinded Phase
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
|
Active Group (AG) Unblinded Phase
After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
Placebo Group (PG) Unblinded Phase
After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
|---|---|---|---|---|
|
Blinded Phase (4 Weeks)
STARTED
|
15
|
15
|
0
|
0
|
|
Blinded Phase (4 Weeks)
COMPLETED
|
12
|
13
|
0
|
0
|
|
Blinded Phase (4 Weeks)
NOT COMPLETED
|
3
|
2
|
0
|
0
|
|
Unblinded Phase (4 Weeks)
STARTED
|
0
|
0
|
12
|
13
|
|
Unblinded Phase (4 Weeks)
COMPLETED
|
0
|
0
|
10
|
10
|
|
Unblinded Phase (4 Weeks)
NOT COMPLETED
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Active Group (AG) Blinded Phase
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
Placebo Group (PG) Blinded Phase
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
|
Active Group (AG) Unblinded Phase
After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
Placebo Group (PG) Unblinded Phase
After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
|
|---|---|---|---|---|
|
Blinded Phase (4 Weeks)
Lost to Follow-up
|
3
|
2
|
0
|
0
|
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
Baseline characteristics by cohort
| Measure |
Placebo Group (PG)
n=13 Participants
Placebo Group (PG) The PG (n=15) will be undergoing TENS therapy with a sham device as described in the AG. The sham device is identical to the active device in all respects except that it stimulates for 6 minutes during each therapy session instead of 60 minutes, and is therefore 10% of the dose.
Electrical Stimulation - Placebo: Subjects will receive a placebo electrical stimulation device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Active Group (AG)
n=12 Participants
Active group (AG). The AG (n=15) will be undergoing TENS therapy with an active device during 4 weeks. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
Electrical Stimulation - Active: Subjects will receive an active electrical stimulation device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.38 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
51.08 years
STANDARD_DEVIATION 12.32 • n=7 Participants
|
45.28 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.76 kg/m^2
STANDARD_DEVIATION 5.98 • n=5 Participants
|
27.72 kg/m^2
STANDARD_DEVIATION 7.92 • n=7 Participants
|
27.74 kg/m^2
STANDARD_DEVIATION 6.95 • n=5 Participants
|
|
High Blood Pressure
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 4 weeksPopulation: Blinded phase of the study at 4 weeks.
Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)
|
0.454 score on a scale
Standard Error 0.503
|
0.198 score on a scale
Standard Error 0.503
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)
|
1.184 score on a scale
Standard Error 0.815
|
0.289 score on a scale
Standard Error 0.255
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Blinded phase of the study.
Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue).
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=10 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)
|
2.821 score on a scale
Standard Error 1.504
|
2.231 score on a scale
Standard Error 3.207
|
SECONDARY outcome
Timeframe: at 4 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)
|
1.13 seconds
Standard Deviation 0.03
|
1.16 seconds
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: at 4 weeksPopulation: blinded phase
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)
|
106.42 steps/min
Standard Deviation 10.35
|
105.90 steps/min
Standard Deviation 10.13
|
SECONDARY outcome
Timeframe: at 4 weeksPopulation: blinded phase
Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)
|
22.84 percentage of time
Standard Deviation 3.98
|
22.64 percentage of time
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: at 4 weeksPopulation: blinded phase
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)
|
103.40 steps/min
Standard Deviation 17.36
|
103.40 steps/min
Standard Deviation 14.84
|
SECONDARY outcome
Timeframe: at 4 weeksPopulation: blinded phase
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)
|
122.57 steps/min
Standard Deviation 15.87
|
122.57 steps/min
Standard Deviation 14.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Stride Time at 4 Weeks During a Dual Walking Task (Blinded Phase)
|
1.19 seconds
Standard Deviation 0.21
|
1.19 seconds
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Stride Time at 4 Weeks During a Fast Walking Task (Blinded Phase)
|
1.00 seconds
Standard Deviation 0.13
|
1.00 seconds
Standard Deviation 0.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksPopulation: Blinded phase of study
Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Outcome measures
| Measure |
Intervention Group
n=12 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=18 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 Weeks (Blinded Phase)
|
150.93 Hertz
Standard Deviation 7.44
|
154.44 Hertz
Standard Deviation 8.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 weeksPopulation: blinded phase of study
Frailty will be measured with a upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index \>0.27 is considered are considered as frail. Patients with a frailty index \<0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=13 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Frailty at 4 Weeks (Blinded Phase)
|
0.18 frailty index
Standard Deviation 0.04
|
0.21 frailty index
Standard Deviation 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksPopulation: Sural nerve conduction velocity from both right and left lower extremities were measured in each participant
Sural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 4 weeks and value will be compared between groups.
Outcome measures
| Measure |
Intervention Group
n=24 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=26 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sural Nerve Conduction Velocity at 4 Weeks (Blinded Phase)
|
54.96 m/s
Standard Deviation 1.16
|
55.96 m/s
Standard Deviation 1.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 weeksPopulation: bilateral ankle strength was measured in each participant
Ankle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity.
Outcome measures
| Measure |
Intervention Group
n=24 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=26 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Ankle Strength at 4 Weeks (Blinded Phase)
|
7.78 kg
Standard Deviation 0.82
|
7.93 kg
Standard Deviation 1.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 weeksPopulation: blinded phase of study
Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Outcome measures
| Measure |
Intervention Group
n=24 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=26 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Plantar Tissue Oxygen Saturation at 4 Weeks (Blinded Phase)
|
67.46 percentage of oxygen saturation
Standard Deviation .78
|
66.31 percentage of oxygen saturation
Standard Deviation .62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 weeksStep count obtained with the mean 90 percentile will be will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Daily Step Count at 4 Weeks (Blinded Phase)
|
4988.11 steps/day
Standard Deviation 3396.20
|
4887.59 steps/day
Standard Deviation 3594.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 4 weeksDaily sleep duration in hours obtained with the mean 90 percentile will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=10 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sleep Duration at 4 Weeks (Blinded Phase)
|
9.2 hours/day
Standard Deviation 1.39
|
9.3 hours/day
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksPopulation: Sural nerve amplitude will be measured in each of the participant's legs
Sural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 4 weeks.
Outcome measures
| Measure |
Intervention Group
n=20 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=24 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sural Nerve Amplitude at 4 Weeks (Blinded Phase)
|
14.4 microVolts
Standard Deviation 6.23
|
16.04 microVolts
Standard Deviation 12.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from week 4 to week 8Population: week 4 to week 8
Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere. This outcome assesses the difference between the mean BPI interference composite score at week 8 and week 4.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=10 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Functional Interference From Pain at 8 Weeks (Unblinded Phase)
|
0.29 score on a scale
Standard Deviation 2.03
|
-0.87 score on a scale
Standard Deviation 1.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks to 8 weeksPain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain. This outcome assesses the difference between the mean BPI severity composite score at week 8 and week 4.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Pain Severity From 4 Weeks to 8 Weeks (Unblinded Phase)
|
0.53 score on a scale
Standard Deviation 1.09
|
-0.43 score on a scale
Standard Deviation 1.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks to 8 weeksFunctional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue). This outcome assesses the difference between the mean global fatigue index at week 8 and week 4.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=9 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Change in Functional Interference From Fatigue From 4 Weeks to 8 Weeks (Unblinded Phase)
|
-0.39 score on a scale
Standard Deviation 7.91
|
2.14 score on a scale
Standard Deviation 5.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=8 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Stride Time at 8 Weeks During a Simple Walking Task (Unblinded Phase)
|
1.15 seconds
Standard Deviation 0.10
|
1.16 seconds
Standard Deviation 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksGastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).
Outcome measures
| Measure |
Intervention Group
n=10 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=8 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 8 Weeks (Unblinded Phase)
|
148.90 Hertz
Standard Deviation 6.60
|
148.52 Hertz
Standard Deviation 6.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksFrailty will be measured with an upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index \>0.27 is considered are considered as frail. Patients with a frailty index \<0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=10 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Frailty at 8 Weeks (Unblinded Phase)
|
0.19 frailty index
Standard Deviation 0.07
|
0.19 frailty index
Standard Deviation 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksSural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 8 weeks and value will be compared between groups.
Outcome measures
| Measure |
Intervention Group
n=14 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=14 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sural Nerve Conduction Velocity at 8 Weeks (Unblinded Phase)
|
55.64 m/s
Standard Deviation 5.02
|
56.04 m/s
Standard Deviation 5.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksAnkle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity.
Outcome measures
| Measure |
Intervention Group
n=20 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=20 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Ankle Strength at 8 Weeks (Unblinded Phase)
|
9.59 kg
Standard Deviation 5.11
|
9.79 kg
Standard Deviation 5.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksPercentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.
Outcome measures
| Measure |
Intervention Group
n=20 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=18 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Plantar Tissue Oxygen Saturation at 8 Weeks (Unblinded Phase)
|
67.82 percentage of oxygen saturation
Standard Deviation 3.79
|
67.38 percentage of oxygen saturation
Standard Deviation 3.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Starting at 4 weeks up to 8 weeksStep count obtained with the mean 90 percentile will be will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US)
Outcome measures
| Measure |
Intervention Group
n=2 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=5 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Mean Daily Step Count at 8 Weeks (Unblinded Phase)
|
3545.86 steps/day
Standard Deviation 4569.65
|
4166.31 steps/day
Standard Deviation 3897.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Starting at 4 weeks up to 8 weeksDaily sleep duration in hours obtained with the mean 90 percentile will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US)
Outcome measures
| Measure |
Intervention Group
n=2 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=3 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sleep Duration at 8 Weeks (Unblinded Phase)
|
2.64 hours/day
Standard Deviation 1.83
|
10.53 hours/day
Standard Deviation 2.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 8 weeksSural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 8 weeks.
Outcome measures
| Measure |
Intervention Group
n=14 lower extremities
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=14 lower extremities
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Sural Nerve Amplitude at 8 Weeks (Unblinded Phase)
|
14.71 microVolts
Standard Deviation 7.47
|
14.71 microVolts
Standard Deviation 6.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksDouble Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Outcome measures
| Measure |
Intervention Group
n=10 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=12 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Double Support Phase at 4 Weeks During a Dual Walking Task (Blinded Phase)
|
24.45 percentage time
Standard Deviation 8.47
|
24.45 percentage time
Standard Deviation 8.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 4 weeksDouble Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Outcome measures
| Measure |
Intervention Group
n=11 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=11 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Double Support Phase at 4 Weeks During a Fast Walking Task (Blinded Phase)
|
17.87 percentage time
Standard Deviation 4.63
|
17.87 percentage time
Standard Deviation 4.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksDouble Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=8 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Double Support Phase at 8 Weeks During a Simple Walking Task (Unblinded Phase)
|
20.69 percentage time
Standard Deviation 4.77
|
21.75 percentage time
Standard Deviation 4.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksDouble Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=7 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
|---|---|---|
|
Double Support Phase at 8 Weeks During a Dual Task (Unblinded Phase)
|
24.47 percentage
Standard Deviation 3.24
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24.51 percentage
Standard Deviation 2.27
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OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
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Placebo Group
n=7 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
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Stride Time at 8 Weeks During a Dual Task (Unblinded Phase)
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1.21 seconds
Standard Deviation 0.15
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1.27 seconds
Standard Deviation 0.15
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OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksStride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=7 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
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|---|---|---|
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Stride Time at 8 Weeks During a Fast Walk Task (Unblinded Phase)
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0.99 seconds
Standard Deviation 0.11
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1.04 seconds
Standard Deviation 0.10
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OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksCadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=8 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
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|---|---|---|
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Cadence at 8 Weeks During a Simple Walking Task (Unblinded Phase)
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105.36 steps/min
Standard Deviation 10.16
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101.63 steps/min
Standard Deviation 5.77
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OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksCadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=9 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=7 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
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|---|---|---|
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Cadence at 8 Weeks During a Dual Task (Unblinded Phase)
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100.51 steps/min
Standard Deviation 12.56
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96.04 steps/min
Standard Deviation 10.62
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OTHER_PRE_SPECIFIED outcome
Timeframe: at 8 weeksCadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute.
Outcome measures
| Measure |
Intervention Group
n=8 Participants
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - Functional: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 1 hour daily for up to 4 weeks.
|
Placebo Group
n=7 Participants
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - Placebo: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 1 hour daily for up to 4 weeks.
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|---|---|---|
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Cadence at 8 Weeks During a Fast Walking Task (Unblinded Phase)
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122.80 steps/min
Standard Deviation 14.88
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116.14 steps/min
Standard Deviation 12.59
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Adverse Events
Intervention Group at 4 Weeks (Blinded Phase)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Group at 4 Weeks (Blinded Phase)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Intervention Group at 8 Weeks (Unblinded Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group at 8 Weeks (Unblinded Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group at 4 Weeks (Blinded Phase)
n=15 participants at risk
The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.
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Placebo Group at 4 Weeks (Blinded Phase)
n=15 participants at risk
The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes).
TENS - low-dose: Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day.
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Intervention Group at 8 Weeks (Unblinded Phase)
n=12 participants at risk
After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.
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Placebo Group at 8 Weeks (Unblinded Phase)
n=13 participants at risk
After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis.
TENS - high-dose: Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.
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|---|---|---|---|---|
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Product Issues
Minor AE due to device misuse
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20.0%
3/15 • AEs were collected from study start date (March 1 2022) to the study completion (December 1, 2023) in a non-systematic way. Per patient, AEs were collected up to 8 weeks after Baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence (assessed by monitoring device usage remotely) the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
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20.0%
3/15 • AEs were collected from study start date (March 1 2022) to the study completion (December 1, 2023) in a non-systematic way. Per patient, AEs were collected up to 8 weeks after Baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence (assessed by monitoring device usage remotely) the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
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0.00%
0/12 • AEs were collected from study start date (March 1 2022) to the study completion (December 1, 2023) in a non-systematic way. Per patient, AEs were collected up to 8 weeks after Baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence (assessed by monitoring device usage remotely) the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
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0.00%
0/13 • AEs were collected from study start date (March 1 2022) to the study completion (December 1, 2023) in a non-systematic way. Per patient, AEs were collected up to 8 weeks after Baseline. During follow-ups, participants were asked if they experienced AEs. If participant missed a visit or had low adherence (assessed by monitoring device usage remotely) the coordinator called the participant and asked for AEs. AEs were also reported by the participants on a case-by-case basis when they occurred.
The clinicaltrials.gov definitions were used. We collected unfavorable medical occurrences experienced by study participants and noted whether they were study device related (caused directly by the device), unrelated to the study device, or whether it was caused by improper device usage. This information was collected non-systematically and not separately -- either participants reported events directly or during phone calls/study visits study coordinators asked about issues.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place