Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061584) titled 'Safety and Feasibility of Physiotherapy using Knee-Ankle-Foot Orthosis for Patients with Acute Stroke
A-single center Randomized Controlled Study' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Sapporo Medical University
Condition:
Condition - stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety and feasibility of intensive standing/walking exercise using Knee-ankle-foot orthosis for patients with acute stroke
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Intervention group
Standing and walking exercises while wearing a Knee-ankle-foot orthosis, to be started within 10 days of onset and performed for at least 20 minutes per day
Continue for up to 14 days of hospitalization; if discharged before then, the program ends on the date of discharge
Interventions/Control_2 - Control group
Standard,usual physiotherapy
Standing and walking exercises while wearing a Knee-ankle-foot orthosis are permitted
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Cerebral infarction or hemorrhage, excluding TIA and aSAH
Aged 18 years or older, but under 90 years
Hospitalization within 48 hours of symptom onset
mRS score of 0 to 2 prior to symptom onset
Condition stabilized within 9 days of onset, allowing for standing exercises
FAC0 to 1, less than BRS of lower limb5 at the time of enrollment
Regardless of whether thrombolytic therapy or thrombectomy was performed
Key exclusion criteria - Patients with obesity, BMI of 35 or higher
Patients unable to cooperate with exercises due to severe impaired consciousness or higher brain dysfunction
Patients with severe ataxia that significantly impairs exercise performance
Patients with musculoskeletal problems in the lower limbs or trunk that significantly impair exercise performance
Patients with a history of fragility fractures in the lower limbs or trunk
Patients with severe medical conditions that impair exercise performance
Palliative care has been selected
Unable to cooperate with exercises
Consent for study participation not obtained within 9 days of admission
Using assistive devices, robotics intended to stabilize the knee joint
Individuals deemed by the physical therapist to be capable of standing and walking exercises without a Knee-ankle-foot orthosis
Not eligible for Knee-ankle-foot orthosis wearing, due to weight, physique, skeletal structures
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 01 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2027 Year 08 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070455
Disclaimer: Curated by HT Syndication.
