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A study on the effect of 3D printing orthotics on the spasm of wrist and hand joint flexor muscle with hemiplegia after stroke

A study on the effect of 3D printing orthotics on the spasm of wrist and hand joint flexor muscle with hemiplegia after stroke

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070454
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-04-12
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

stroke

Interventions

Experimental group:Regular rehabilitation training + Wearing 3D printing orthotics (6 weeks)
Control group:Regular rehabilitation training + Wearing traditional orthotics (6 weeks)

Sponsors

Shanghai Xuhui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for cerebral infarction or cerebral hemorrhage; 2. Hemiplegia left after cerebrovascular accident for the first time; 3. Patients with wrist flexion spasm >=1+ grade (MAS), metacarpophalangeal joint, proximal interphalangeal joint, distal interphalangeal joint flexion spasm >=1 grade (MAS); 4. Aged 30-85 years; 5. Onset of disease is 2-12 months; 6. Ability to understand command actions; 7. The patient's vital signs are stable; 8. Enrolled patients did not change the dose of antispasmodic drugs taken during the treatment and follow-up period; 9. Voluntary signatories of informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous motor dysfunction, such as rheumatoid arthritis, joint deformity, spinal cord injury and other diseases that have a direct impact on motor function; 2. Previous block therapy with botulinum toxin, alcohol and phenol; 3. Previously performed orthopaedic surgery for wrist joints; 4. Patients who have local pressure sores or are allergic to materials and are not easy to wear auxiliary devices; 5. Wrist and hand joint flexion spasm >= grade 4; 6. Hemiplegic side sensory function disappeared.

Design outcomes

Primary

MeasureTime frame
Improved Ashworth evaluation;Subjective feeling score;

Secondary

MeasureTime frame
Positive range of motion;The simplify Fugl-Meyer score;Pain visual analog score;Swelling score;MRI and f-MRI;

Countries

China

Contacts

Public ContactXu Ying

Shanghai Xuhui Central Hospital

xzxywk2@126.com+86 13764314136

Outcome results

None listed

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