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Effects and mechanism of training with the robotic exoskeleton on walking dysfunction in stroke patients

Effects and mechanism of training with the robotic exoskeleton on walking dysfunction in stroke patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056787
Enrollment
Unknown
Registered
2022-02-17
Start date
2022-02-17
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

stroke

Interventions

General training intensity group:On the basis of standardized routine rehabilitation training, add exoskeleton robot walking training 1 session/day, 30min/session, 5 sessions/week for 4 weeks.
High training intensity group:On the basis of standardized routine rehabilitation training, add exoskeleton robot walking training 2 sessions/day, 30min/session, 10 sessions/week for 4 weeks.
Control group:On the basis of standardized routine rehabilitation training, add traditional walking training 1 session/day, 30min/session, 5 sessions/week for 4 weeks.

Sponsors

China Rehabilitation Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?Patients in stable condition with stroke occurring in the anterior circulation diagnosed according to the 2010 China Guidelines for the Prevention and Treatment of Cerebrovascular Diseases; ?18-70 years old, first onset of stroke, 1-3 months after stroke; ?Functional Walking Scale (FAC) grades 0-2; ?Body size that could fit into the exoskeleton robot: height range: 155-190cm, maximal weight 100kg, lower limb Ashworth classification<3.

Exclusion criteria

Exclusion criteria: ?Previous neurological diseases; ?Significant cognitive impairment or speech disorder, unable to cooperate with treatment and evaluation; ?Severe heart, lung, liver, kidney or other vital organ diseases; ?Severe orthostatic hypotension; ?Severe osteoporosis , arthritis or orthopedic disease, limited passive range of lower limbs; ? Unsuitable for exoskeleton robot; ?Metallic foreign bodies in the body, unable to perform functional magnetic resonance scan.

Design outcomes

Primary

MeasureTime frame
functional ambulation category scale,FAC;

Secondary

MeasureTime frame
Fugl-Meyer motor function assessment-lower extremity,FM-LE;Rivermead motor index, RMI;Berg balance scale;functional independence measure, FIM;functional magnetic resonance imaging,fMRI;

Countries

China

Contacts

Public ContactSun Xinting

China Rehabilitation Research Center

sunxinting@163.com13146806907

Outcome results

None listed

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