Dynamic Hot Spring Hydrotherapy for Gait Disorders and Balance Function Recovery After Stroke

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Second Affiliated Hospital of Kunming Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dynamic hot spring hydrotherapy intervention

    Other intervention

    Under 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 intervention

    Under 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

80 Participants
are divided into 2 treatment groups
Group A: Conventional rehabilitation interventionSham comparator 1 intervention
Group B: Dynamic hot spring hydrotherapy interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the end of treatment at 2 weeks.
2

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.

Time frame
From enrollment to the end of treatment at 2 weeks.
3

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

Time frame
From enrollment to the end of treatment at 2 weeks.
4

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.

Time frame
From enrollment to the end of treatment at 2 weeks.

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 2 weeks
2

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.

Time frame
From enrollment to the end of treatment at 2 weeks
3

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.

Time frame
From enrollment to the end of treatment at 2 weeks
4

Neurotransmitters and Cytokines

β - endorphin, tumor necrosis factor - α (TNF - α), and interleukin-6 (IL-6)

Time frame
From enrollment to the end of treatment at 2 weeks

Other outcomes

Sponsors and contacts

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