Comparing high and low-frequency high-intensity training for stroke recovery
High vs Low-frequency of High-intensity Training in Chronic Stroke
This study is testing whether more frequent high-intensity walking training helps people who have had a stroke recover their walking ability better than less frequent training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06612723 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore how the frequency of high-intensity gait training affects locomotor outcomes in individuals who have experienced a stroke. Participants will be randomly assigned to either a high-frequency training group, receiving 18 sessions over 6 weeks, or a low-frequency group, receiving the same training over 12 weeks. The study will assess outcomes at 6, 12, and 24 weeks post-training to determine the effectiveness of each approach. The focus is on improving gait and overall community mobility through structured rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who have experienced a unilateral stroke more than 6 months prior and can ambulate with some assistance.
Not a fit: Patients with uncontrolled cardiopulmonary or metabolic diseases, or those with significant neurological impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke survivors, leading to improved mobility and quality of life.
How similar studies have performed: While similar studies have explored high-intensity training for stroke rehabilitation, this specific comparison of training frequency is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months * Age 18-85 * Weight \< 350 pounds * Able to follow 3-step commands * Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed * Lower extremity Fugl-Meyer \< 34 * Medical clearance to participate Exclusion Criteria: * Evidence of cerebellar ataxia * Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study. * Currently participating in other physical therapy * \>50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months
Where this trial is running
Indianapolis, Indiana
- Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Thomas G Hornby, PhD — Indiana University
- Study coordinator: Christopher Henderson, PhD
- Email: henderce@iu.edu
- Phone: 317-329-2353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.