Error-augmented Walking on Gait Performance and Brain Activities in Stroke

Healthy Clinical Trial

Official title:

The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455334
• Other study ID #: 202004042RIND
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2022
• Source: National Taiwan University Hospital
• Contact: Yanci Liu, Ph.D
• Phone: 0233668135
• Email: yanciliu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This three-year study is proposed to document the effect and further implementation of error-augmented walking on gait performance and brain activities in individuals with stroke. Note that brain activations of post-stroke individuals during locomotion is a relatively unexplored realm. In the first year, study aims to observe the gait performance and brain activity of post-stroke and healthy participants when they walk on the split-belt treadmill, which inputs errors and causing adaptation during locomotion. Second year, study focuses on the long-term effect in aspect of brain activation and gait performance after training the post-stroke individuals with error-augmented treadmill walking. Lastly, study aim to investigate the long-term effect of practically applying the concept of error-augmented training strategy into clinical physical therapy.

The first-year study is a cross-sectional study to recruit post-stroke and healthy participants. Gait performance will be measured by GaitUp system and brain activity during each walking trails will be measured concurrently by functional near infrared spectroscopy (fNIRS). Cadence, stride time, stride length and swing cycle are the gait parameters that will be recorded. Also, symmetry ratio and variability of temporal and spatial parameters will also be calculated. Brain area of interest in this study will be bilateral premotor cortex (PMC), supplementary motor area (SMA) and medial part of primary motor cortex (M1). Study will run one-way analysis of variance (ANOVA) with repeated measures and, if needed, Tukey post hoc test will be used to document the within group and between group differences with p<.05.

The second year and third year study are single-blinded (assessor), randomized controlled trials. In the second year, study will recruit and randomize post-stroke participants into one of the two training groups, error-augmented treadmill training group (ETT group) and active control group (AC group). In ETT group, participants will practice split-belt treadmill walking. And participants in AC group will received traditional treadmill walking. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. There will be three evaluations, chronologically, on one day before intervention, one day after completion of intervention and one month after completion of intervention. Gait performance, brain activity, dynamic gait index and sensorimotor ability of lower extremity will be documented. Two-way ANOVA and Tukey post-hoc test will be used to determine the training and follow-up effects with p< .05. During the third year, individuals with stroke will be recruited and randomized to one of the two group, error-augmented concept combined physical therapy group (EAPT group) and conventional physical therapy group (CPT group). Participants in the CPT group will receive thirty-minute conventional physical therapy each session. Instead of training on a split-belt treadmill, participants in EAPT group will receive fifteen-minute walking trainings that implement the error-augmented concept and another fifteen-minute conventional physical therapy each session. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. The outcome measurements, and statistical analysis are the same as those described in the second year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

The inclusion criteria of stroke participants are

1. first unilateral stroke

2. older than 20 years old

3. medically stable

4. lesion site limited in subcortical area

5. having step length asymmetry (asymmetry ratio = 1.08)

6. ability to walk 10 meters independently without an assistive device.

The inclusion criteria of healthy participants are

1. ability to walk 10 meters independently without an assistive device

2. no any other neurological, psychological, or orthopedic disorders known to interfere the walking performance

3. mini-mental status examination scores > 24 points

The exclusion criteria are

1. Participants who are medical unstable

2. cognitive impaired (mini-mental status examination scores < 24 points)

3. diagnosed with other neurological, psychological, or orthopedic disorders known to interfere the participation to the study

4. with the diagnosis which the contraindication includes exercise

Related Conditions & MeSH terms

• Healthy
• Stroke

Intervention

Other:
• Error-augmented treadmill training
walk on split-belt treadmill
• active control group
walk on tie-belt treadmill
• Error-augmented concept combined physical therapy group
Error-augmented concept combined physical therapy
• conventional physical therapy group
conventional physical therapy
• NO INTERVENTION
NO INTERVENTION

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dynamic Gait Index		Change from Baseline cadence at 4 weeks
Other	Dynamic Gait Index		Change from Baseline cadence at 8 weeks
Other	Fugl-Meyer assessment	Sensorimotor impairment of lower extremity	Change from Baseline cadence at 4 weeks
Other	Fugl-Meyer assessment	Sensorimotor impairment of lower extremity	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - Cadence	The unit is steps per minutes	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - Cadence	The unit is steps per minutes	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - stride time	The unit is seconds	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - stride time	The unit is seconds	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - stride length	The unit is cm	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - stride length	The unit is cm	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - swing cycle	The unit is percentage (%)	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - swing cycle	The unit is percentage (%)	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - symmetry ratio	V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - symmetry ratio	V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)	Change from Baseline cadence at 8 weeks
Primary	Change of walking performance - variability	CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)	Change from Baseline cadence at 4 weeks
Primary	Change of walking performance - variability	CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)	Change from Baseline cadence at 8 weeks
Secondary	Brain activities over premotor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Secondary	Brain activities over premotor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks
Secondary	Brain activities over supplementary motor area	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Secondary	Brain activities over supplementary motor area	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks
Secondary	Brain activities over primary motor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Secondary	Brain activities over primary motor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks