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New treatment option for Stroke
Official title Alternative Therapies for Improving Physical Function in Individuals With Stroke
ClinicalTrials.gov ID: NCT03869138
What this study is testing
- What it's testing
- Neurological impairment is a devastating disease for patients and their families and a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Participants should be 18 to 90 years of age.
- Able to follow instructions provided in English.
- History of neurological impairment (Stroke, Parkinson's disease and Multiple Sclerosis) for at least 6 months prior to evaluation (self-report...
- Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
- Cognitive skills to actively participate (score of \< 26 on Montreal cognitive assessment indicates cognitive impairment) (30).
You likely can't join if
- 1\. Significant cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment indicates cognitive impairment...
- 2\. Presence of concurrent severe medical illness, including unhealed pressure sores, active or untreated infection, thromboembolic disease, severe...
- 3\. History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major...
- 4\. Partcipants unavailable for 12 weeks of participation, 5. Current participation in other treatment (i.e.- Botox) or other research studies during...
- 6\. Pregnancy. 7. Uncontrolled pain \>3/10 on VAS 8. Complains of shortness of breath 9. Uncontrolled hypertension (systolic blood pressure (SBP) \>...
- 10\. Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) [3].
See the full eligibility criteria
- Participants should be 18 to 90 years of age.
- Able to follow instructions provided in English.
- History of neurological impairment (Stroke, Parkinson's disease and Multiple Sclerosis) for at least 6 months prior to evaluation (self-report, confirmed by participant's physician).
- Able to stand and walk with or without assistive device or braces as part of their activities of daily living (self-report).
- Cognitive skills to actively participate (score of \< 26 on Montreal cognitive assessment indicates cognitive impairment) (30).
- Stroke - a) Upper extremity limb function (score of at least 25 on the Fugyl Myer Upper extremity test and Muscle performance grade on deltoid, pec major and and triceps of \> or = 2/5).
- Parkinson's disease a) - Stable medication use b) stage I or II of the Boher classification of Parkinson's disease c) No sudden fluctuations (on-off phenomenon).
- Multiple Sclerosis - No Severe disability "Expanded Disability Status Scale" (EDSS scale \< or = 4.5).
- 1\. Significant cognitive or communicative impairment indicated by a score of \> 26 on Montreal cognitive assessment indicates cognitive impairment. In neurologically impaired individuals, for cognitive impairment a...
- 2\. Presence of concurrent severe medical illness, including unhealed pressure sores, active or untreated infection, thromboembolic disease, severe contractures, active heterotrophic ossification in the lower...
- 3\. History of any acute and significant cardiopulmonary, musculoskeletal or systemic diagnosis in the past 6 months or history of a recent major surgery (\<6months) or hospitalization (\<3months) and on any sedative...
- 4\. Partcipants unavailable for 12 weeks of participation, 5. Current participation in other treatment (i.e.- Botox) or other research studies during the phase of the study.
- 6\. Pregnancy. 7. Uncontrolled pain \>3/10 on VAS 8. Complains of shortness of breath 9. Uncontrolled hypertension (systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during...
- 10\. Resting hear rate (HR) \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age) [3].
- 11\. Oxygen saturation (measured by pulse oximeter) during resting \< 95%. 12. Severe cardiac disease (New York Heart Association classification of II-IV) [1].
- 13\. Exclusion Criteria for Laboratory Slip test. i. T score of \< -2 on the Bone density, measured through via the heel ultrasound machine. It must be noted that the particpants will be explained that they were...
- ii. Partcipants with \> 250 lbs in weight or with a BMI OF \>35Kg/m2. It should be noted that the harness system is capable of tolerating up to 300 lbs of weight safely.
- iii. Unable to walk a length of 8 meters without cane two times with a rest break in between the two walks, lasting shorter than five minutes.
- iv. Unable to stand for at least 5 minutes (to accommodate length of a dance song) as assessed by decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic measured by the a research team member.
- Please note that the exclusion criteria for the Laboratory Slip test will only exclude participants from taking this test. They will still be part of the study if other inclusion /exclusion criteria are met and will go...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.