Clinical trial NCT06764290: Neural Changes in Stroke Patients During Challenging Walking Tasks.
Official title: Neural Mechanism Changes in Stroke Patients During Challenging Environments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Electroencephalography
gait rehablitation
challenging task
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients, including outpatients and inpatients.

Brief summary: For stroke patients, a challenging, unfamiliar, and more difficult task may increase the likelihood of brain activation to stimulate recovery. Pedal walking and walking with eyes-covered are both difficult and challenging tasks for stroke patients. The investigators intend to study the biomechanics and neural mechanisms of challenging pedal walking and walking with eyes covered.

Stroke participants will wear electroencephalogram electrode caps and perform three tasks: walking on a flat surface for 60 seconds, walking on pedal for 60 seconds, and walking with eyes covered for 60 seconds.

Detailed description: Stroke participants will wear a 32-lead electroencephalogram electrode cap (Zhentai Technology Company, Xi 'an, China), first walk on a flat ground for 60 seconds, rest for 2 minutes, then walk on the pedal for 60 seconds, rest again for 2 minutes, and walk for 60 seconds with eyes-covered.

Eligibility criteria: Inclusion Criteria:

* First-time occurrence of stroke confirmed by computed tomography or magnetic resonance imagingClinical diagnosis of stroke
* Disease duration of more than 14 days， less than 1 year
* Able to walk independently but with a lingering abnormal gait

Exclusion Criteria:

* Lesions accumulate in the brainstem
* Lesions accumulate in the cerebellum
* Impaired vision
* Severe cognitive impairment

Primary outcomes:
measure: Weight Phase Lag Index
timeFrame: The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds
measure: Relative power
timeFrame: The study was an observational cross-sectional study with data collected at the same time as the trial was being conducted, so the duration was 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Geriatric Hospital of Nanjing Medical University, 269 Qingmen Street
state: Jiangsu
city: Nanjing
country: China
facility: Geriatric Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Geriatric Hospital of Nanjing Medical University
name: Xia Li Zhang, doctor
role: STUDY_DIRECTOR
References:
citation: Krakauer JW. Motor learning: its relevance to stroke recovery and neurorehabilitation. Curr Opin Neurol. 2006 Feb;19(1):84-90. doi: 10.1097/01.wco.0000200544.29915.cc.
citation: Fettrow T, Hupfeld K, Tays G, Clark DJ, Reuter-Lorenz PA, Seidler RD. Brain activity during walking in older adults: Implications for compensatory versus dysfunctional accounts. Neurobiol Aging. 2021 Sep;105:349-364. doi: 10.1016/j.neurobiolaging.2021.05.015. Epub 2021 May 31.
citation: Kulkarni A, Cui C, Rietdyk S, Ambike S. Humans prioritize walking efficiency or walking stability based on environmental risk. PLoS One. 2023 Apr 7;18(4):e0284278. doi: 10.1371/journal.pone.0284278. eCollection 2023.