Peony and licorice decoction fumigation treatment for strephenopodia after stroke: study protocol for a randomized controlled pilot trial

Phase 1

• Conditions: poststroke strephenopodia

• Registration Number: ITMCTR2000003253
• Lead Sponsor: Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. confirmed stroke patients with results from computed tomography (CT) or magnetic resonance imaging (MRI);
2. aged between 35 and 75 years, male or female;
3. first episode of stroke or with a history of stroke but with no serious neurofunctional disablility and modified Ranking Scale (mRS) grade <= 2;
4. stable condition after stroke and within 6 months of the duration;
5. with strephenopodia and be able to walk at least 6 meters;
6. blood pressure lower than 160/100 mmHG;
7. sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score >=24;
8. never used fumigation treatment before;
9. the patients or their legal guardian sign an informed consent.

Exclusion Criteria

1. received surgery or thrombolytic therapy;
2. duration of stroke more than 6 months;
3. stroke without strephenopodia or with but could not walk 6 meters;
4. vital signs are not stable or with worsening conditions such like new infarction or bleeding;
5. combined with other cerebral diseases such as subarachnoid hemorrhage, cerebral hemorrhage, brain tumor, brain trauma and so on;
6. combined with lumbar vertebrae disease, knee joint disease, foot disease and other diseases that can affect the patient's walking gait;
7. combined with severe dysfunction of heart, lung, liver, kidney and blood system;
8. combined with moderate to severe cognitive comprehension or visual impairment that can affet rehabilitation treatment or gait examination;
9. pregnant or lactating women;
10. participating in other clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medial planter area;

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment;Barthel Index;Modified Ashworth Scale;Berg Balance Scale;Stroke-Specific Quality of Life Scale;