Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke

Stroke Clinical Trial

Official title:

Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565185
• Other study ID #: ErenkoyPTRH
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: Erenköy Physical Therapy and Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

Description:

There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rehabilitation need for stroke

• Patients under FAC stage 4

• No contraindications for robotic rehabilitation

• Subacute stroke

Exclusion Criteria:

• The robot-orthosis does not fit the patient's body

• Inadequate body weight (obesity)

• Severe contractures

• Bone instability (nonstable spinal cord fracture and severe osteoporosis)

• Circulation problems

• Cardiac problems

• Open wounds on the lower extremities or in the body where they will come into contact with the orthosis

• Uncoordinated, psychotic or aggressive patients

• Serious cognitive disorders

• Patients with long-term infusion therapy

• Hip, knee, ankle arthrodesis

• Epilepsy

• Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia

• Those with severe vascular problems of the lower extremity

• Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases

• Severe respiratory diseases

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• robot-assisted gait training
Investigators will use robot-assisted gait training for rehabilitation of stroke
• placebo
Investigators will use only conventional treatment without robot-assisted gait training

Locations

Country	Name	City	State
Turkey	Erenkoy physical treatment and rehabilitation hospital	Istanbul	In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Erenköy Physical Therapy and Rehabilitation Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test	6 minute walk test for walking speed	4 weeks
Primary	10 meter walking test	10 meter walking test for walking	4 weeks
Primary	Postural Assessment Scale for Stroke(PASS)	Postural Assessment Scale for Stroke(PASS) will be used	4 weeks
Secondary	FAC(Functional Ambulation Classification)	FAC will be used for ambulation	4 weeks
Secondary	Barthel Index	Barthel Index will be used for daily living activities	4 weeks