Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059482) titled 'A Study to Evaluate the Effectiveness of Machine-Assisted Gait Training in Patients with Stroke' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, functional electrical stimulation (FES) is applied to the gastrocnemius and soleus muscles of hemiparetic patients during body weight-supported walking. The aim is to identify the optimal combination of electrical stimulation and body weight support level. This study is expected to broaden the rehabilitation options for hemiparetic patients who exhibit diverse gait patterns. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - FES to the soleus muscle,0% BWS (no unloading) Interventions/Control_2 - FES to the soleus muscle,15% BWS

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - Chronic stroke patients with hemiparesis who are able to walk independently, excluding those who require walking aids. Key exclusion criteria - 1.CognitiveCognitive impairment, as assessed by the Mini-Mental State Examination (MMSE).  Participants scoring 27 or lower on the MMSE will be excluded.

2.Cardiac diseases, including heart failure, angina pectoris, or other life-threatening arrhythmias.

3.Respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or lung cancer.

4.Allergies to medications or metals.

5.Markedly reduced exercise tolerance.

6.Contraindications to functional electrical stimulation (FES) used in this study, including:

Abnormal pain, numbness, or sensory disturbances in the affected lower limb, Presence of a pacemaker, Metal implants in the lower limbs, Skin disorders, History or suspicion of epilepsy

7.Participants whose gait does not show a clear difference from that of healthy individuals, or who do not exhibit obvious impairment in push-off during gait, which is the focus of this study.

8.Individuals who require walking aids.

9.Those who require more than one hour of round-trip transportation to and from the research site.

10.Individuals who have difficulty gripping handrails or operating switches. Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 11 Month 14 Day Anticipated trial start date - 2025 Year 11 Month 15 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067956

Disclaimer: Curated by HT Syndication.