Trial Outcomes & Findings for DDN in Stroke--COBRE (NCT NCT05196737)
NCT ID: NCT05196737
Last Updated: 2024-11-20
Results Overview
H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN
Results posted on
2024-11-20
Participant Flow
Participants were enrolled in a cross-sectional study. Eleven participants were enrolled in the non-intervention week, of which 9 participants completed all visits. Those 9 participants went on to the Dry Needling Reflex Measurements, of which 8 participants completed all visits. So 11 participants were enrolled, and 8 completed the study procedures.
Participant milestones
| Measure |
Non-Intervention Week Reflex Measurements
Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week.
|
|---|---|
|
Non-intervention Week
STARTED
|
11
|
|
Non-intervention Week
Timepoint 1/Pre-DDN
|
9
|
|
Non-intervention Week
Timepoint 2/Post Immediate DDN)
|
9
|
|
Non-intervention Week
Timepoint 3/Post 90 Minutes DDN
|
9
|
|
Non-intervention Week
Timepoint 4/Post 24 Hours DDN
|
9
|
|
Non-intervention Week
Timepoint 5/Post 72 Hours DDN
|
9
|
|
Non-intervention Week
COMPLETED
|
9
|
|
Non-intervention Week
NOT COMPLETED
|
2
|
|
Dry Needling Reflex Measurment Week
STARTED
|
9
|
|
Dry Needling Reflex Measurment Week
Timepoint 1/Pre-DDN
|
9
|
|
Dry Needling Reflex Measurment Week
Timepoint 2/Post Immediate DDN)
|
9
|
|
Dry Needling Reflex Measurment Week
Timepoint 3/Post 90 Minutes DDN
|
9
|
|
Dry Needling Reflex Measurment Week
Timepoint 4/Post 24 Hours DDN
|
9
|
|
Dry Needling Reflex Measurment Week
Timepoint 5/Post 72 Hours DDN
|
8
|
|
Dry Needling Reflex Measurment Week
COMPLETED
|
8
|
|
Dry Needling Reflex Measurment Week
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Non-Intervention Week Reflex Measurements
Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week.
|
|---|---|
|
Non-intervention Week
Lost to Follow-up
|
2
|
|
Dry Needling Reflex Measurment Week
Protocol Violation
|
1
|
Baseline Characteristics
DDN in Stroke--COBRE
Baseline characteristics by cohort
| Measure |
Single Arm
n=11 Participants
Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week.
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDNPopulation: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDNPopulation: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDNPopulation: Due to equipment malfunction, we could not obtain data with adequate quality for this analysis.
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion.
Outcome measures
| Measure |
Single Arm
n=8 Participants
All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Dry Needling Reflex Measurements
n=8 Participants
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Post-90 Min
90 minutes after DDN
|
Post-24 Hrs
24 hours after DDN, single timepoint at this visit
|
Post-72 Hrs
72 hours after DDN, single timepoint at this visit
|
|---|---|---|---|---|---|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee extended) baseline
|
0.5 maximum degrees of dorsiflexion
Standard Deviation 4.09
|
0 maximum degrees of dorsiflexion
Standard Deviation 3.89
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee extended) 0-min post
|
0 maximum degrees of dorsiflexion
Standard Deviation 4.62
|
0.5 maximum degrees of dorsiflexion
Standard Deviation 3.83
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee extended) 90-min post
|
0 maximum degrees of dorsiflexion
Standard Deviation 5.26
|
3 maximum degrees of dorsiflexion
Standard Deviation 3.93
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee extended) 72 hour post
|
0 maximum degrees of dorsiflexion
Standard Deviation 6.20
|
0 maximum degrees of dorsiflexion
Standard Deviation 11.51
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee extended) baseline
|
-28.5 maximum degrees of dorsiflexion
Standard Deviation 10.92
|
-24.5 maximum degrees of dorsiflexion
Standard Deviation 8.94
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee extended) 0-min post
|
-26 maximum degrees of dorsiflexion
Standard Deviation 11.36
|
-22.5 maximum degrees of dorsiflexion
Standard Deviation 7.14
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee extended) 90-min post
|
-26.5 maximum degrees of dorsiflexion
Standard Deviation 9.34
|
-22 maximum degrees of dorsiflexion
Standard Deviation 9.24
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee extended) 72-hr post
|
-22 maximum degrees of dorsiflexion
Standard Deviation 11.51
|
-21 maximum degrees of dorsiflexion
Standard Deviation 12.06
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee flexed) post-0 min DDN
|
4 maximum degrees of dorsiflexion
Standard Deviation 8.30
|
8 maximum degrees of dorsiflexion
Standard Deviation 3.70
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee flexed) post-90 min DDN
|
2.5 maximum degrees of dorsiflexion
Standard Deviation 6.57
|
8 maximum degrees of dorsiflexion
Standard Deviation 4.93
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM post-72 hr DDN
|
4.5 maximum degrees of dorsiflexion
Standard Deviation 4.64
|
5.5 maximum degrees of dorsiflexion
Standard Deviation 5.28
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee flexed) baseline
|
-24.5 maximum degrees of dorsiflexion
Standard Deviation 13.80
|
-14 maximum degrees of dorsiflexion
Standard Deviation 12.71
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee flexed) post-0 min DDN
|
-20 maximum degrees of dorsiflexion
Standard Deviation 8.29
|
-16 maximum degrees of dorsiflexion
Standard Deviation 10.23
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee flexed) post-90 min DDN
|
-19 maximum degrees of dorsiflexion
Standard Deviation 6.85
|
-15.5 maximum degrees of dorsiflexion
Standard Deviation 9.52
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
active DF ROM (with knee flexed) post-72 hr DDN
|
-17 maximum degrees of dorsiflexion
Standard Deviation 10.92
|
-15.5 maximum degrees of dorsiflexion
Standard Deviation 13.15
|
—
|
—
|
—
|
|
Ability to Move the Limb as Measured by Range of Motion (ROM)
passive DF ROM (with knee flexed) baseline
|
2.5 maximum degrees of dorsiflexion
Standard Deviation 6.00
|
5.5 maximum degrees of dorsiflexion
Standard Deviation 5.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34.
Outcome measures
| Measure |
Single Arm
n=8 Participants
All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Dry Needling Reflex Measurements
n=8 Participants
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Post-90 Min
90 minutes after DDN
|
Post-24 Hrs
24 hours after DDN, single timepoint at this visit
|
Post-72 Hrs
72 hours after DDN, single timepoint at this visit
|
|---|---|---|---|---|---|
|
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity
Median FMA-LE score baseline
|
22 score on a scale
Standard Deviation 5.00
|
20 score on a scale
Standard Deviation 5.23
|
—
|
—
|
—
|
|
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity
Median FMA-LE score 0-min post
|
24 score on a scale
Standard Deviation 5.01
|
19.5 score on a scale
Standard Deviation 5.19
|
—
|
—
|
—
|
|
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity
Median FMA-LE score 90 min post
|
22.5 score on a scale
Standard Deviation 5.68
|
21 score on a scale
Standard Deviation 4.78
|
—
|
—
|
—
|
|
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity
Median FMA-LE score 72 hr post
|
22.5 score on a scale
Standard Deviation 5.44
|
21 score on a scale
Standard Deviation 4.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDNThe mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the mAS
Outcome measures
| Measure |
Single Arm
n=7 Participants
All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Dry Needling Reflex Measurements
n=7 Participants
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Post-90 Min
n=7 Participants
90 minutes after DDN
|
Post-24 Hrs
n=7 Participants
24 hours after DDN, single timepoint at this visit
|
Post-72 Hrs
n=7 Participants
72 hours after DDN, single timepoint at this visit
|
|---|---|---|---|---|---|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 1
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 2
|
3 score on a scale
|
2 score on a scale
|
2 score on a scale
|
2 score on a scale
|
3 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 4
|
2 score on a scale
|
1.5 score on a scale
|
1.5 score on a scale
|
2 score on a scale
|
2 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 5
|
2 score on a scale
|
2 score on a scale
|
2 score on a scale
|
2 score on a scale
|
3 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 6
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 8
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
3 score on a scale
|
|
Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)
Participant 14
|
1.5 score on a scale
|
1.5 score on a scale
|
1.5 score on a scale
|
1 score on a scale
|
1 score on a scale
|
SECONDARY outcome
Timeframe: 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDNPopulation: No pain was reported by any participant throughout the study. All participants reported "0" pain at all time points.
Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain.
Outcome measures
| Measure |
Single Arm
n=8 Participants
All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Dry Needling Reflex Measurements
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Post-90 Min
90 minutes after DDN
|
Post-24 Hrs
24 hours after DDN, single timepoint at this visit
|
Post-72 Hrs
72 hours after DDN, single timepoint at this visit
|
|---|---|---|---|---|---|
|
Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain
|
0 score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.Decreased time indicates improved ability to walk
Outcome measures
| Measure |
Single Arm
n=8 Participants
All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Dry Needling Reflex Measurements
n=8 Participants
All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.
Dry Needling: Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
|
Post-90 Min
90 minutes after DDN
|
Post-24 Hrs
24 hours after DDN, single timepoint at this visit
|
Post-72 Hrs
72 hours after DDN, single timepoint at this visit
|
|---|---|---|---|---|---|
|
Change in Time Needed to Walk 10 Meter (10 m Walk Test)
Median 10MWT time in seconds at baseline
|
9.525 seconds
Standard Deviation 2.61
|
7.91 seconds
Standard Deviation 2.25
|
—
|
—
|
—
|
|
Change in Time Needed to Walk 10 Meter (10 m Walk Test)
Median 10MWT time in seconds 90 min post
|
9.515 seconds
Standard Deviation 2.52
|
8.1 seconds
Standard Deviation 2.00
|
—
|
—
|
—
|
|
Change in Time Needed to Walk 10 Meter (10 m Walk Test)
Median 10MWT time in seconds 24 hours post
|
8.175 seconds
Standard Deviation 1.99
|
7.57 seconds
Standard Deviation 2.44
|
—
|
—
|
—
|
|
Change in Time Needed to Walk 10 Meter (10 m Walk Test)
Median 10MWT time in seconds 72 hours post
|
7.945 seconds
Standard Deviation 1.90
|
7.555 seconds
Standard Deviation 2.13
|
—
|
—
|
—
|
Adverse Events
Non-Intervention Week Reflex Measurements
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dry Needling Reflex Measurements
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gretchen Seif, PT, DPT, MHS, OCS, FAAOMPT
Medical University of South Carolina
Phone: (843) 792-9345
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place