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The Effect of an Integrated Acupuncture Point Stimulation and Motion Intelligent Ankle Joint Rehabilitation Device on Ankle Dorsiflexion Function and Walking Ability in Stroke Patients

The Effect of an Integrated Acupuncture Point Stimulation and Motion Intelligent Ankle Joint Rehabilitation Device on Ankle Dorsiflexion Function and Walking Ability in Stroke Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002325
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Stroke

Interventions

All enrolled patients:In the first phase, conventional rehabilitation training is provided for 2 weeks, with each phase involving 5 consecutive days of treatment per week, once daily, and each session
All enrolled patients:Following the completion of the first phase, rest for 1 week before proceeding to the second phase, which involves training with an intelligent ankle joint rehabilitation device

Sponsors

China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for stroke; (2) First episode, with onset within 3 months to less than 1 year; (3) Age between 40 and 75 years, gender; (4) Conscious, with stable vital signs, good cognitive function, and able to actively cooperate with treatment and related assessments; (5) Manual muscle strength assessment of the lower extremities is = Grade 3, Modified Ashworth Scale = 1+ grade, and has ankle dorsiflexion dysfunction or insufficient ankle dorsiflexion; (6) No pre-existing balance dysfunction, with the affected lower extremity in Brunnstrom stage = III; (7) Holden walking ability is = Grade III; (8) Voluntarily participates and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a cardiac pacemaker or those with severe dysfunction or critical conditions in vital organs such as the heart, liver, lungs, kidneys, and hematopoietic system; (2) Patients with severely restricted joint mobility, limiting walking ability; (3) Patients with skin injuries or infections in the lower limbs or device-wearing areas, or those with allergic constitutions and allergies to multiple medications or electrode patches; (4) Patients with fractures that have not fully healed; (5) Patients with untreated deep vein thrombosis; (6) Patients with lower limb motor dysfunction not caused by stroke; (7) Patients deemed to have poor compliance and unable to complete the study as required. Any patient meeting any of the above 7 criteria meets the exclusion criteria and will not be included in this trial.

Design outcomes

Primary

MeasureTime frame
pace;Ankle Joint Maximum Dorsiflexion Angle (Affected Side);pace;Duration of stance phase and swing phase (affected side);

Secondary

MeasureTime frame
Berg Balance;Barthel Index;

Countries

China

Contacts

Public ContactDanqiang An

China Academy of Traditional Chinese Medicine, Xiyuan Hospital

andanqiang@163.com+86 13691202926

Outcome results

None listed

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