Skip to content

The Clinical Efficacy of Extracorporeal Shock Wave Therapy in Treating Lower Limb Spasticity in Stroke Patients with Varied Initial Muscle Lengths

The Clinical Efficacy of Extracorporeal Shock Wave Therapy in Treating Stroke-Induced Spasticity at Various Initial Muscle Lengths

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113227
Enrollment
Unknown
Registered
2025-11-26
Start date
2024-01-12
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke spasm

Interventions

Control group:Bobath technique is used as the main physical therapy for routine rehabilitation. The passive movement of all joints of the affected limb, including scapular band activity, ranging from
Relaxation group:In the relaxation group, on the basis of conventional rehabilitation treatment, extracorporeal shock wave was used to treat the abdominal muscles of the calf triceps muscle back and f
Draft group:In the stretching group, on the basis of conventional rehabilitation treatment, the assistant first carried out continuous passive drafting of the calf triceps, and then used extracorporea

Sponsors

Huashan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation, the subjects have no mental disorders, can fully understand and cooperate with this trial, and are willing to sign the consent form. If the subjects are hemiplegic on the dominant side and unable to sign, their legal representatives can sign the informed consent form with their consent. 2.They meet the diagnostic criteria for stroke formulated by the Fourth National Academic Conference on Cerebrovascular Diseases and have a clear diagnosis confirmed by head CT or MRI. 3.They have unilateral hemiplegia, with a modified Ashworth scale score of the ankle plantar flexor muscle group on the hemiplegic side greater than grade 1, and normal muscle tone on the non-hemiplegic side. 4.They have had their first stroke or have had lacunar infarction in the past without sequelae. 5.The course of stroke in the subjects is 2 months to 1 year, and the condition is stable. 6.Age range: 18 to 80 years old, gender and handedness are not limited. 7.Consciousness is clear, auditory comprehension is basically normal, and they can cooperate with treatment and assessment. 8.There is no obvious discomfort during changes in body position (the subjects are assisted by two people to transfer from bed to wheelchair), blood pressure, heart rate, and breathing are stable, and there is no pain, chest tightness, shortness of breath, dizziness, headache or other discomfort. They can tolerate the supine or prone position for 30 minutes. 9.They have a certain walking ability with or without the assistance of a walking aid.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of diabetes and other conditions that may cause peripheral nerve damage, Parkinson's disease and other conditions that may cause high muscle tone, and those with concurrent muscle diseases; 2.Those with severe cognitive, speech, vision, hearing impairments (such as deaf-mutes) or mental disorders that affect examination and treatment; 3.Those with concurrent tumors, severe respiratory, heart, liver, kidney, endocrine and hematopoietic system diseases, such as patients with congestive heart failure, uncontrolled hypertension, blood pressure higher than 140/90mmHg, active liver disease, liver and kidney insufficiency; 4.Those with joint disorders in the measured joint itself (such as severe infection, contracture, joint surgery, rheumatoid or rheumatoid arthritis); 5.Those with contraindications for nerve electrophysiology, ultrasound assessment, and extracorporeal shock wave therapy (such as bleeding disorders, patients with coagulation dysfunction that may cause local tissue bleeding, presence of thrombosis in the treatment area, severe cognitive and mental disorders, skin damage, fever, history of tumors, pregnancy, lactation, etc.); 6.Those taking drugs that affect muscle tone, and those who have received botulinum toxin injections within the last 3 months; 7.Those currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth scale score ;Fugl-Meyer Motor Function scale score (Lower limbs);

Secondary

MeasureTime frame
Mofidied Tardieu scale score;Barthel index scale score ;10 meter pace test;Neurophysiological examination (H-reflex of the tibial nerve);

Countries

China

Contacts

Public ContactJiang Liujun

Huashan Hospital affiliated to Fudan University

1729046116@qq.com+86 153 0040 0417

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026