NCT04436627

Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical practice. This study aims to develop an end-effector RT treatment protocol and to examine the preliminary effects of the treatment protocol on UE motor function in patients with stroke.

Detailed description

There are two objectives in this case series study. One is combining external scientific evidence with clinical expertise to design a detailed training protocol for RT in patients with different severity of stroke. The other is to examine the effects on UE motor function and explore the client perspective. The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II\~III /10 for stage IV /15 for stage V\~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Amadeo-assisted training-1	Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training.
DEVICE	Amadeo-assisted training-2	Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release).
DEVICE	Amadeo-assisted training-3	Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot.

Timeline

• Start date: 2020-02-07
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-06-18
• Last updated: 2021-05-17

Locations

1 site across 1 country: Taiwan