rTMS and Robotic Gait Training in Patients With Stroke

Stroke Clinical Trial

Official title:

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) and Robotic Gait Training on Lower-extremity Function and Gait in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03817385
• Other study ID #: CCH-160102
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: Changhua Christian Hospital
• Contact: PangTa Liu
• Phone: 886-4-7238595
• Email: 105546[@]cch.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with stroke have demonstrated abnormal muscle tone and postural control ability which affect their ambulation, activity of daily living and confident. Nowadays, utilizing repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking training for stroke patients has been applied to clinic widely. While less studies have compared intervention efficacy for stroke patients between rTMS and robotic training. This study aimed to compare effect of rTMS and robotic training for lower-extremity function and gait in stroke patients.

Description:

This study will include subjects occurring stroke within 3 months. All groups will receive traditional rehabilitation. The subjects will be allocated randomly in three groups which are traditional rehabilitation (Group A), robotic training (Group B), and rTMS (Group C) respectively, with 35 people per group. The group B will be intervened 5 times per week and the group C will receive 10 times rTMS intervention during 4 weeks. At post-intervention and eighth weeks after intervention, basic examination will be executed including basic information, history, Mini-mental State examination, Short -Form 36, Modified Ashworth Scale, Fugl-Meyer assessment, static and dynamic motion examination, ultrasound assessment and examination of cardiorespiratory. Two-way mixed ANOVA will be used to analyze the differences of three groups and times.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• first-time onset of stroke

• reaching 20 years old and having clinical CT and MRI diagnosis of stroke

• hemiparesis with sitting ability after onset 3 months

Exclusion Criteria:

• Brunnstrom stage over grade V

• Combined other neurological diseases (epilepsy, polyneuropathy, Meniere's disease, vestibular neuritis, Parkinson's disease, dementia, spinocerebellar ataxia)

• lower extremity disease, included joint contracture, high muscle tone(MAS more than 3), L/E fracture, Joint replacement, long-term osteoarthritis pain

• unstable vital sign

• can't coordinate or Sign consent plan form

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• repetitive TMS
rTMS x 10 times
• robotic GT
robotic gait training for 20 times

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

Brunt D, Greenberg B, Wankadia S, Trimble MA, Shechtman O. The effect of foot placement on sit to stand in healthy young subjects and patients with hemiplegia. Arch Phys Med Rehabil. 2002 Jul;83(7):924-9. — View Citation

Dettmann MA, Linder MT, Sepic SB. Relationships among walking performance, postural stability, and functional assessments of the hemiplegic patient. Am J Phys Med. 1987 Apr;66(2):77-90. — View Citation

Hidler J, Nichols D, Pelliccio M, Brady K. Advances in the understanding and treatment of stroke impairment using robotic devices. Top Stroke Rehabil. 2005 Spring;12(2):22-35. Review. — View Citation

Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum in: Stroke.2008 Aug;39(8): e143. — View Citation

Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. — View Citation

Kakuda W, Abo M, Watanabe S, Momosaki R, Hashimoto G, Nakayama Y, Kiyama A, Yoshida H. High-frequency rTMS applied over bilateral leg motor areas combined with mobility training for gait disturbance after stroke: a preliminary study. Brain Inj. 2013;27(9):1080-6. doi: 10.3109/02699052.2013.794973. — View Citation

Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112. — View Citation

Kim P, Warren S, Madill H, Hadley M. Quality of life of stroke survivors. Qual Life Res. 1999 Jun;8(4):293-301. — View Citation

Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. Epub 2005 Sep 8. — View Citation

Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. — View Citation

Nichols DS. Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 May;77(5):553-8. Review. — View Citation

Wang RY, Tseng HY, Liao KK, Wang CJ, Lai KL, Yang YR. rTMS combined with task-oriented training to improve symmetry of interhemispheric corticomotor excitability and gait performance after stroke: a randomized trial. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):222-30. doi: 10.1177/1545968311423265. Epub 2011 Oct 5. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of walking speed	walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of postural sway displacement	Use computerized dynography to measure the postural sway displacement (mm)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of postural sway velocity	Use computerized dynography to measure the postural sway velocity (mm/s)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of postural sway area	computerized dynography to measure the postural sway area (mm^2)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of step time	Use computerized dynography to measure spatial gait parameter: step time (ms)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of stance time	Use computerized dynography to measure spatial gait parameter: stance time (ms)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of swing time	Use computerized dynography to measure spatial gait parameter: swing time (ms)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of single support time	Use computerized dynography to measure spatial gait parameter: single support time (ms)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of double support time	Use computerized dynography to measure spatial gait parameter: double support time (ms)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of step length	Use computerized dynography to measure spatial gait parameter: step distance (mm)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of stance length	Use computerized dynography to measure spatial gait parameter: stance distance (mm)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of amplitude of Muscle activity	use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self selected speed in 6 meters.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of Functional Independence Measure (FIM)	FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.; The motor subscale includes: Eating Grooming Bathing Dressing, upper body Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchair Transfers - toilet Transfers - bath/shower Walk/wheelchair Stairs; The cognition subscale includes: Comprehension Expression Social interaction Problem solving Memory Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.; The total score for the FIM motor subscale will be a value between 13 and 91. The total score for the FIM cognition subscale will be a value between 5 and 35.; The total score for the FIM instrument will be a value between 18 and 126.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Primary	Change of international Quality of Life Assessment Short Form -36 (SF-36)	including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.; Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of concentration of Serum albumin	The concentration of Serum albumin in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.; Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of concentration of Hemoglobin (Hb)	The concentration of Hb in the blood test.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of concentration of Glucose	The concentration of Glucose in the blood test. The Spot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of concentration of Cholesterol	The concentration of Cholesterol in the blood test.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of concentration of Triglyceride	The concentration of Triglyceride in the blood test.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Berg balance test (BBS)	Including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.; The item scores are summed, minimum score =0, maximum score = 56	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Fugl-Meyer Assessment (FMA)	Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (Upper extremity maximum score = 66; Lower extremity maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Body Mass Index (BMI)	(body weight) kg/(height) m*(height)m	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Mini-mental state examination (MMSE)	It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Modified Ashworth scale (MAS)	measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone; Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM); More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; Considerable increase in muscle tone, passive movement difficult; Affected part(s) rigid in flexion or extension	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
Secondary	Change of Muscle tone	measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.	baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks);robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention