Stroke
Conditions
Brief summary
The goal of this clinical trial is to test ischemic conditioning (blood flow restriction) as a neuromodulatory technique to improve gait function in stroke. Neuromodulation is emerging as a promising adjunct strategy to facilitate changes in brain activity and improve motor behavior following a neurological injury such as stroke. The main questions this trial aims to answer are: * Can ischemic conditioning produce neuromodulatory changes in the lower limb primary motor cortex? * Can ischemic conditioning be used as a neuromodulatory technique to improve strength and motor control in individuals with stroke when compared to sham ischemic conditioning? Participants will take part in two sessions of ischemic conditioning where a cuff (similar to ones that measure blood pressure) will be placed around the thigh and inflated to one of two blood flow restriction pressures (real ischemic conditioning (real IC) and sham ischemic conditioning (sham IC)). Each participant will experience measures of brain activity and motor behavior testing before and after both sessions (real IC and sham IC). Researchers will investigate ischemic conditioning as neuromodulation modality in stroke to see if ischemic conditioning can produce beneficial changes in brain activity and improvements on subsequent motor behavior tasks.
Interventions
DEVICEReal Ischemic Conditioning
10-minute cycles of blood flow restriction (5 minutes) followed by blood flow release (5 minutes), repeated 5 times for a total of 50 minutes.
Sham ischemic conditioning will mirror ischemic conditioning procedures, differing solely in cuff pressure during blood flow restriction to replicate to replicate perceived tightness without arterial blood flow restriction.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be masked to the type of ischemic conditioning they receive (real or sham). Treatment arms/ session order (ischemic conditioning and sham ischemic conditioning) will be randomized.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Single, stroke \> 6 months since onset * Residual hemiparetic gait deficits (e.g., abnormal gait pattern)
Exclusion criteria
* Lesions affecting the brainstem or cerebellum * Other neurological disorders that may interfere with motor function * Unhealed decubiti, persistent infections that may interfere with ability to perform test procedures * Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE\<21)), which could impede the understanding of the purpose of procedures of the study * Botulinum toxin (Botox) treatments to the lower limb within the past 6 months * Pregnant women * Contraindications to transcranial magnetic stimulation (TMS) or ischemic conditioning (IC) (Listed below) TMS General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Corticomotor Excitability | Changes in corticomotor excitability will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC. | Excitability of the primary lower limb motor cortex will be assessed using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the paretic leg. Higher values indicate more corticomotor excitability. |
| Change in Transcallosal Inhibition | Changes in transcallosal inhibition will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC. | Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation. Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere. |
| Change in Ankle Motor Control | Changes in ankle motor control will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC. | Reaction time will be measured using a choice reaction time task involving rapid ankle dorsiflexion and plantarflexion movements in a custom built ankle-tracking device. Lower values reflect faster reaction times. Only dorsiflexion trials were analyzed to isolate TA activation, while both directions were included to minimize anticipatory activity. |
| Change in Lower Limb Strength | Changes in strength will be calculated within and between sessions at baseline (Pre), immediate-post (Post), and 30-minutes-post (Post-30) one session of sham IC and real IC. | Participants will perform 3 trials each of maximum ankle dorsiflexion and plantarflexion strength. Higher values reflect more strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) for Pain | During each real and sham ischemic conditioning session. Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition. | Subjective measures of pain will be reported during ischemic conditioning and sham ischemic conditioning using a Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst pain). Ratings from each session will be averaged for each participant, and the final value will represent the mean pain rating across all participants for each experimental condition. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSangeetha Madhavan, PT, PhD
University of Illinois at Chicago
Participant flow
Pre-assignment details
22 individuals with stroke were screened for eligibility. Of these, 2 were excluded prior to study procedures due to contraindications to IC. Of the 20 eligible participants, 1 withdrew for health reasons unrelated to study procedures (GI tract discomfort). Thus, 19 participants completed the study and experienced one session of IC and one session of sham-IC. All eligibility assessments and consent were conducted in person before randomization/ IC and sham-IC.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 60.9 years STANDARD_DEVIATION 7 |
| Ankle range of motion Dorsiflexion | 4.9 degrees STANDARD_DEVIATION 8.3 |
| Ankle range of motion Plantarflexion | 17.4 degrees STANDARD_DEVIATION 9.2 |
| Endurance | 319.1 m STANDARD_DEVIATION 143.9 |
| Gait Speed | 1.3 m/s STANDARD_DEVIATION 0.44 |
| Limb occlusion pressure | 193.72 mmHg STANDARD_DEVIATION 24.6 |
| Mini-Mental State Examination (MMSE) | 28.6 units on a scale STANDARD_DEVIATION 2 |
| Modified Rankin Scale | 2.7 units on a scale STANDARD_DEVIATION 0.8 |
| Paretic FMLE | 22.3 units on a scale STANDARD_DEVIATION 6.4 |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic/Latino | 4 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex/Gender, Customized Sex/Gender Female | 3 Participants |
| Sex/Gender, Customized Sex/Gender Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 8 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
None listed