Multicenter Study on the Efficacy and Safety of Lower Limb Rehabilitation Robot.

Multicenter Study on the Efficacy and Safety of Lower Limb Rehabilitation Robot using a newly-developed device Exowalk.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003411

Enrollment

144

Registered

2019-01-03

Start date

2018-11-01

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Medical Device : This study on the efficacy and safety of Electromechanical -assisted gait trainer EXOWALK ®(HR-01) is a multicenter, randomized and parallel-group study. All enrolled subjects are pat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) those who had a stroke 2) those who had a score of 10 or more in the Mini-Mental State Examination (MMSE) 3) those who had a Modified Ashworth Scale (MAS) Grade 2 or lower 4) those who could stand alone.

Exclusion criteria

Exclusion criteria: 1) those with poor cognition that made it difficult to carry out instructions 2) those with ataxia that made unstable standing balance 3) those with spasticity MAS Grade 3 or above 4) those with severe leg arthritis 5) those with difficulty walking due to joint problems of the lower leg

Design outcomes

Primary

Measure	Time frame
Functional ambulatory category (FAC), FAC was determined the existence of independent walking through a concise level assessment. Primary endpoints were evaluated once at baseline (pre-intervention) four weeks after the baseline (post-intervention), and four weeks after the last treatment (follow-up). FAC was evaluated by dividing the degree of needing for assistance when walking to 1 to 6. FAC level ranged from Level 1 for ‘nonfunctional’ to Level 6 for ‘independent without help for non-level surfaces’.	—

Measure

Time frame

Functional ambulatory category (FAC), FAC was determined the existence of independent walking through a concise level assessment. Primary endpoints were evaluated once at baseline (pre-intervention) four weeks after the baseline (post-intervention), and four weeks after the last treatment (follow-up). FAC was evaluated by dividing the degree of needing for assistance when walking to 1 to 6. FAC level ranged from Level 1 for ‘nonfunctional’ to Level 6 for ‘independent without help for non-level surfaces’.

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Secondary

Measure	Time frame
Second endpoints had a total of 7 assessments. First, RMI was used to evaluate motor skills. It consisted of 15 questions step by step, depending on the level ranging from bed rotation to running. A total of 15 questions were scored. Each was scored 1 point if yes or 0 if no. The total sum was used as a result of the evaluation. Second, walking velocity as a 10mWT was used to measure the speed during a 10-meter walking. The unit was m/sec (meter per second). Similarly, walking capacity was evaluated with a 6MWT to measure the distance that one could walk for 6 minutes. The unit was m (meter). The fourth item was MI. It was evaluated as 1 to 99 points by measuring the lower leg force level from the ankle to the knee. Assessment items consisted of three questions, each with a score of 0/9/14/19/25/33. The total sum of scores was used as the result of the evaluation. The fifth item was BBS to evaluate the balance ability with 0 to 56 points. There were 14 questions in total. Each question was scored from 0 to 4 points. The total sum of scores was used as the result of the evaluation. The last two evaluation items were measured with motion analysis devices for those who could walk stable without aids. Swing time asymmetry and step length asymmetry were analyzed by HumanTrack (Rbiotech, 1806A_DA004_H1FS, South Korea) a gait analysis system which is capable of performing walking analysis at a distance of 5-7 m without space restriction. The swing time was calculated based on phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. The step length was calculated as the distance between the heel of the foot and the heel of the other foot. Each asymmetry value was calculated as the absolute value difference between the paretic side and the non-paretic side. The physical content of the clinical alteration was reported by auditors, practitioners, and patients at each visit. All indication, data of onset, and period were r	—

Measure

Time frame

Second endpoints had a total of 7 assessments. First, RMI was used to evaluate motor skills. It consisted of 15 questions step by step, depending on the level ranging from bed rotation to running. A total of 15 questions were scored. Each was scored 1 point if yes or 0 if no. The total sum was used as a result of the evaluation. Second, walking velocity as a 10mWT was used to measure the speed during a 10-meter walking. The unit was m/sec (meter per second). Similarly, walking capacity was evaluated with a 6MWT to measure the distance that one could walk for 6 minutes. The unit was m (meter). The fourth item was MI. It was evaluated as 1 to 99 points by measuring the lower leg force level from the ankle to the knee. Assessment items consisted of three questions, each with a score of 0/9/14/19/25/33. The total sum of scores was used as the result of the evaluation. The fifth item was BBS to evaluate the balance ability with 0 to 56 points. There were 14 questions in total. Each question was scored from 0 to 4 points. The total sum of scores was used as the result of the evaluation. The last two evaluation items were measured with motion analysis devices for those who could walk stable without aids. Swing time asymmetry and step length asymmetry were analyzed by HumanTrack (Rbiotech, 1806A_DA004_H1FS, South Korea) a gait analysis system which is capable of performing walking analysis at a distance of 5-7 m without space restriction. The swing time was calculated based on phase of gait begins when the foot first leaves the ground and ends when the same foot touches the ground again. The step length was calculated as the distance between the heel of the foot and the heel of the other foot. Each asymmetry value was calculated as the absolute value difference between the paretic side and the non-paretic side. The physical content of the clinical alteration was reported by auditors, practitioners, and patients at each visit. All indication, data of onset, and period were r

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Countries

Korea, Republic of

Contacts

Public ContactYeongyo Nam

Dongguk University Ilsan Hospital

nyg3583@hanmail.net+82-31-961-8435

Outcome results