Stroke Clinical Trial
— BLT2bOfficial title:
Optimizing Training in Severe Post-Stroke Walking Impairment
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18-80 years of age - Walking speed less than or equal to 0.4 meters/second - Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill - Able to walk independently (cane and hemi-walker acceptable) - Ambulate >10 meters over ground with the Free Step Harness System (as a safety precaution) - Discharged from formal rehabilitation Exclusion Criteria: - Unstable cardiac status which would preclude participation in a moderate-intensity exercise program. - Significant language barrier which might prevent the participant from following instructions during training and testing. - Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect) - Severe lower extremity spasticity (Ashworth >2) - Depression (>10 on the Patient Health Questionnaire, if untreated). |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati College of Medicine | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Temporal Symmetry Index | %-limb support of the affected and unaffected leg, during the 10 MWT | Temporal Symmetry Index | |
Other | Static Balance: Sway Index (SI) | The Biodex Modified Clinical Test of Sensory Interaction on Balance (mSIBT) is a well-validated balance system and has been used neurally intact and neurologically impaired individuals to objectively measure static balance. Compared to other measures of static balance, the mSIBT provides the added benefit of differentiating the contributions of the visual, proprioceptive and vestibular systems. Method: While on the platform (with safety harness), participants will stand with the hands at the side under 4 conditions (30 secs/condition):1) firm surface with the eyes open, 2) firm surface with the eyes closed, 3) compliant surface (foam) with the eyes open, 4) Compliant surface (foam) with the eyes closed. Three attempts will be average and documented as SI. | Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3- Months Post Training | |
Other | Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 3 Meter | Participants will be instructed to sit with the back against the chair (seat height 46cm, arm height 67cm) and on the word "go," stand up, walk at a comfortable speed past the 3-m mark, turn around, walk back, and sit down in the chair. Two trials are averaged and documented in seconds. | Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training | |
Other | Dynamic Balance: Instrumented Timed Up & Go (i-TUG)- 7 Meter | Participants will be instructed to sit with the back against the chair (seat height 46cm, arm height 67cm) and on the word "go," stand up, walk at a comfortable speed past the 7-m mark, turn around, walk back, and sit down in the chair. Two trials are averaged and documented in seconds. | Baseline, One Day Post-Training, One month Post Training, 3- Months Post Training | |
Primary | Change in 10-Meter Walk (fast) | Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second. | Pre-Baseline (Day of Randomization) to One Day Post-Training | |
Secondary | 10-Meter Walk Test (Fast- Retention) | Two 10MWT (fast) trials (using a stop-watch) are averaged and documented in meters/second. | One Day Post Training, One month Post Training, 3- Months Post Training | |
Secondary | 10-Meter Walk (Comfortable) | Two 10MWT trials (using a stop-watch) are averaged and documented in meters/second. | Baseline (Day of Randomization), One Day Post-Training, One month Post Training, 3-Months Post Training |
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