Robot Assisted Gait Training in Patients With Infratentorial Stroke

Stroke Clinical Trial

Official title:

The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680691
• Other study ID #: NRC-2015-01-002
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: March 1, 2018
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Effect of Robot Assisted Gait Training in Patients With Infratentorial Stroke

Description:

The hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with infratentorial stroke

• Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

• chronic neurological pathology

• orthopedic injuries

• femur lengths of less than 34cm

• severely limited range of lower extremity joint motion

• medical instability

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Robot, then conventional training
Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline
• Conventional, then robot training
Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Berg Balance Scale at 4 Weeks	Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life	Baseline and 4 weeks from baseline
Secondary	Berg Balance Scale	Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Trunk impairment scale	Trunk impairment scale performs to evaluate the sitting balance and trunk control ability examining static sitting balance, dynamic sitting balance, and coordination	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Functional Ambulation Category	Categorizes patients according to basic motor skills necessary for functional ambulation. It represents the status of ambulation	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	10m walk test	10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Fugl-Meyer Assessment	Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Korean version of Falls efficacy scale	Asseses perception of balance and stability during activities of daily living Assesses fear of falling in the elderly population	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Scale for the assessment and rating of ataxia	Scale for the assessment and rating for infratentorial stroke	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary	Balance test using force plate	Each subject performs the following four tasks resembling Romberg test: standing with their feet positioning with the distance between their shoulders with eyes open (FSEO) or closed (FSEC), and standing with their feet together with eyes open (FTEO) or closed (FTEC). Each task is performed for 20 seconds and repeat for three times.	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

External Links

•   Site of the present study