Clinical trial NCT06955182: Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke
Official title: Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our research aims to analyze and compare the improvement of various indicators of gait disorders and balance function before and after dynamic hot spring hydrotherapy and conventional exercise intervention, and clarify the therapeutic effect of dynamic hot spring hydrotherapy on gait disorders and balance function in stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with cerebral infarction or cerebral hemorrhage who meet the diagnostic criteria for stroke of the Chinese Medical Association; (2) Initial stroke\<6 months, or last stroke event\>6 months; (3) Age\>=18 years old,\<85 years old (increased risk of VCI over 85 years old); (4) NIHSS\>4, NIHSS\<26 points; (5) MRS score\>=2 points; (6) complete CT or MRI; (7) No serious neurological or mental illness; Unconscious disorders, able to cooperate with relevant treatments; No severe cognitive impairment (MMSE\>=15 points); (8) Berg Balance Scale\>40 points; (9) The patient or family member signs an informed consent form.

Exclusion Criteria:

* (1) Concurrent major diseases, such as heart, lung, liver, kidney and other organ diseases or failure; (2) There are contraindications for hydrotherapy such as acute infectious diseases, open skin wounds, and severe epilepsy; (3) There are other clinical issues that may affect the assessment results, such as low vision, fractures, vestibular diseases, etc; (4) There are other neurological disorders, such as multiple sclerosis, Parkinson's disease, etc; (5) Serious mental and psychological problems exist; (6) Malignant tumor patients; (7) Early pregnancy or high-risk pregnancy; (8) Serious alcohol abusers; (9) Patients with active bleeding, such as gastrointestinal bleeding, nosebleeds, and excessive menstruation.

Primary outcomes:
measure: Timed Up and Go Test, (TUG)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: 10 Meter Walk Test, (10WMT)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Berg Balance Scale, BBS
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Fugl-Meyer Balance Assessment,（FMA-B)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Forced Vital Capacity, (FVC).
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: FEV1
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Maximum Voluntary Ventilation, (MVV)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: oxygen consumption per kg body weight, (VO2/Kg)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: METS
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Respiratory Quotient, (RQ)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VE
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: breathing reserve ratio
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Tidal Volume, (VT)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Heart Rate, (HR)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VO2/WR
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: The oxygen pulse (VO2/HR)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VO2@AT
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: PetCO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: PetO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VE/VO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: VE/VCO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: SpO2
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: HR_1_minute
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: P Syst
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: P Diast
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Step Length
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Stride Length
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Step Width
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Cadence
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Walking Speed
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Stance Phase
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Swing Phase
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Double Support
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Hip joint
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Knee joint
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Ankle joint
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Pelvic movements
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Ground Reaction Force (GRF)
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Joint Moments
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Power
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Symmetry Index
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Phase Coordination
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Center of gravity position
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Center of gravity swing amplitude
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Center of gravity swing frequency
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Walking stability
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Posture transition ability
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Disturbance response ability
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Visual dependence level
timeFrame: From enrollment to the end of treatment at 2 weeks.
measure: Muscle activity pattern
timeFrame: From enrollment to the end of treatment at 2 weeks.
Secondary outcomes:
measure: anxiety
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: sleep quality
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Self efficacy
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: Neurotransmitters and Cytokines
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
Locations:
city: Kunming
country: China
facility: Electroencephalography
state: Yunnan
Study officials:
References: