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Effectiveness of Saebo Glove orthosis applied to constraint-induced movement therapy on upper limb motor function in patients with stroke.

Effectiveness of Saebo Glove orthosis applied to constraint-induced movement therapy on upper limb motor function in patients with stroke.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042590
Enrollment
Unknown
Registered
2021-01-23
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

Stroke

Interventions

Saebo Glove Orthosis Group:Saebo glove orthosis and restraint glove
Restraint Glove Group:restraint glove
Control Group:regular treatment

Sponsors

North Campus, Huashan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The first onset, which meets the diagnostic criteria adopted by the 4th National Cerebrovascular Disease Conference, and is confirmed by head CT or MRI, and indicates a unilateral lesion; (2) Age 18~60 years; (3) The range of motion of the upper extremity joint meets the following conditions: active flexion and extension, abduction, and external rotation of the affected side shoulder joint >= 45 degrees C, the affected side elbow joint can be extended from the fully flexed position >= 20 degrees C, and the affected side forearm pronation and supination >= 45 degrees C; active back extension of the affected wrist joint >= 20 degrees C, extension of the metacarpophalangeal joint and any two interphalangeal joints of the finger >= 10 degrees C; thumb abduction >= 10 degrees C, and the action can be repeated 3 times within 1 min; (4) Have a certain desire for rehabilitation and family support; (5) The course of disease is less than 6 months.

Exclusion criteria

Exclusion criteria: (1) Severe heart, lung and other organ diseases; (2) Severe cognitive impairment and aphasia; (3) Severe upper limb joint pain; (4) Subluxation of the shoulder joint; (5) Obvious balance disorder; (6) Brunnstrom staging of upper limbs = 3 grade.

Design outcomes

Primary

MeasureTime frame
Wolf scale;Motor Activity Log;Action Research Arm Test;

Secondary

MeasureTime frame
Modified Tardieu Scale;Triple Spasticity Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;Surface Electromyography;Motor Evoked Potential;

Countries

China

Contacts

Public ContactHuang SongHua

North Campus, Huashan Hospital of Fudan University

songwow55@163.com+86 13651656241

Outcome results

None listed

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