About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
(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.
Trial design
Parallel
Treatments tested in this trial
Dynamic hot spring hydrotherapy intervention
Other interventionUnder closed management, patients will receive 5 times a week, 20 minutes of routine rehabilitation and 20 minutes of hot spring water exercise each time: (1) 20 minutes of routine rehabilitation: including routine muscle strength enhancement training, joint range of motion training, and neuropathological methods (Bobath method, proprioceptive neuromuscular facilitation technique, etc.); (2) 20 minute hot spring water balance walking function training
Conventional rehabilitation intervention
Other interventionUnder closed management, patients will receive routine physical therapy for 40 minutes 5 times a week: 1) 20 minutes of routine rehabilitation, including routine muscle strength enhancement training, joint range of motion training, and neuropathological methods (Bobath method, proprioceptive neuromuscular facilitation technique, etc.); 2) 20 minute land balance walking function training
Treatment groups
Trial outcomes
Primary outcomes
Timed Up and Go Test, (TUG)
Timed Stand Up Walking Test (TUG) Assess gait based on the time required for the test subject to stand up from the chair, walk at a steady pace to the 3-meter mark, and then return to the chair to sit down. The evaluation results are as follows: \<10 seconds: Normal activity ability, low risk of falling. 10-14 seconds: There may be mild functional impairment, further evaluation is needed. \>14 seconds: The risk of falling significantly increases (such as in elderly people or Parkinson's disease patients). \>20 seconds: Prompt for severe mobility impairment, requiring intervention (such as in post-stroke patients).
10 Meter Walk Test, (10WMT)
Individuals walk 10 meters and have participants conduct 3 trials at a comfortable walking speed, followed by 3 trials at the patient's fast walking speed. Measure the middle 6 meters, allowing for acceleration and deceleration. The timing starts when the toe of the current foot crosses the 2-meter mark; The timer ends when the toe of the current foot crosses the 8-meter mark; In units of s, accurate to two decimal places; Calculate the average for each walking speed. The actual speed is 6m divided by the recorded seconds to obtain the speed in m/s. The speed rating results are as follows: \<0.4m/s can be used for family walking 0.4-0.8m/s allows for limited community walking \>0.8m/s can be used for community walking If the test subject requires full assistance, a score of 0 should be recorded.
Berg Balance Scale, BBS
The BBS consists of 14 projects, including sitting to stand, standing independently, sitting independently, standing to sit, bed chair transfer, standing with closed eyes, standing with both feet together, extending the upper limbs in the standing position, picking up objects from the ground in the standing position, turning around to look back, turning around once, alternating steps with both feet, standing on one leg, etc. Each project is rated from 0 to 4 points based on the patient's completion status, with a total score of 56 points. The evaluation results are as follows: 41-56 points: Good balance function, low risk of falling 21-40 points: There is a certain degree of decline in balance function, and the risk of falling is moderate 0-20 points: Severe impairment of balance function, high risk of falling
Fugl-Meyer Balance Assessment,(FMA-B)
The ability of the test subject to complete various balance test items, including unsupported sitting; Healthy side "spreading wings" reaction; The completion of the "spreading wings" reaction on the affected side, standing with support, standing without support, standing on the healthy side, and standing on the affected side will be scored. Each examination item will be scored on a scale of 0-2 points, with the highest score of 14 points and the lowest score of 0 points. If the score is less than 14 points, it indicates that the balance function is impaired. The lower the score, the more severe the balance dysfunction.
Secondary outcomes
anxiety
Beck Anxiety Inventory Scoring is based on the severity of anxiety symptoms, and the total score is calculated by adding up each result. Scores 15-25 indicate mild anxiety, 26-35 indicate moderate anxiety, and scores above 36 indicate severe anxiety.
sleep quality
Pittsburgh Sleep Quality Index (PSQI) According to the various indicators of sleep quality, the frequency is divided into 0-5 points: good sleep quality, 6-10 points: decent sleep quality, 11-15 points: average sleep quality, 16-21 points: poor sleep quality.
Self efficacy
ABC Balanced Confidence Scale Based on the confidence level of each item, ranging from 0% (no confidence) to 100% (completely confident), the total score is taken as the average of all items. ≥ 80%: Good balance and confidence, low risk of falling; 50%\~80%: moderate risk; \<50%: High risk, requiring intervention.
Neurotransmitters and Cytokines
β - endorphin, tumor necrosis factor - α (TNF - α), and interleukin-6 (IL-6)
Sponsors and contacts
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