Development and Evaluation of a Novel Portable Robotic Gait Rehabilitation in Chronic Stroke
NCT ID: NCT03444688
Last Updated: 2018-04-10
Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-04-02
2018-12-10
Brief Summary
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Detailed Description
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Recruited subjects will have 19 study visits. The recruited 100 subjects will be divided into 2 groups of 50 each through a simple randomization scheme; 1) Conventional gait training (CT, control group) and 2) Gait rehabilitation with the new walker modified after 1st stage (WT, experimental group). Each subject will undergo training programs consisting of 45 minutes training session (excluding rest periods), 3 days (alternate) a week for 6 consecutive weeks.
Subjects allocated to the CT group will receive physiotherapy program, including active assisted or passive range of motion and conventional gait and balance training. The subjects will first perform active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. Subjects will then perform conventional gait and balance therapy based on the proprioceptive neuromuscular facilitation (PNF) concept for 15 minutes. Among the PNF techniques, investigators will facilitate pelvic motion to improve control and mobility of the subjects. Subjects will be given a 5 minutes rest. Finally, the CT subjects will undergo the over-ground gait training with or without aid or orthoses and with manual assistance from senior physiotherapist for 15 minutes, depending on the individual subject's abilities.
For WT group, subjects will first go through active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. The main therapy consists of 2 parts with 5 minutes rest in between. During part 1, subjects will be trained on the robotic walker with the help of active body weight support (BWS) and functional electrical stimulation (FES) for 15 minutes with pelvic motion support function and lateral balance function being continuously provided. The level of BWS will be provided as much as the subjects can support his or her residual body weight (10% to 30% BWS). The BWS force will be gradually reduced as soon as the subjects can support his or her full body weight. The clinical criterion for the reduction is that the subjects show the ability to move his or her hips and are able to support his or her own body weight sufficiently on the affected lower limb and straighten their legs during the single-leg stance phase. Therapists will be able to control the level of BWS force according to the criteria mentioned above. FES will be used to stimulate the peroneal nerve in the affected side, and the intensity of the device will be painlessly controlled by allowing sufficient dorsiflexion and eversion during the swing phase. FES will be set to synchronize with the inertial measurement unit (IMU) sensors and the stimulation timing for the common peroneal nerve will based on the detected gait phase by IMU sensors. During part 2, subjects will also receive resistance/assistance forces on top of the BWS and FES training for 15 minutes. The decision on providing resistance or assistance modes will be made according to the subjects' functional ambulation category (FAC) level. For subjects with FAC level less than 3, the assistive function will be implemented, otherwise resistive function will be applied. The assistance and resistance forces will be applied proportional to the BW of the subjects (2% to 7% of BW), which is determined by therapists. The rationale of dividing the WT group into 2 parts of different training is that the 1st part is to provide basic locomotive function with persistent and repetitive sensory stimulation while the 2nd part is to add task-specificity to improve weight-bearing, aerobic, functional strengthening and balance for the neurologically challenged patients by implementing a variety of walking tasks. Investigators expect that the repetitive and persistent walking with task-specific gait training will promote better functional outcomes than the conventional gait therapy.
During the session, subjects can request for a rest anytime if they experience discomfort or fatigue. Additionally, investigators will provide them with a 5 - 15 minutes of rest time. The rest period given depends on individual subjects' needs. Investigators will seek their opinion whether subjects have enough rest and are well to continue with the session. Longer rest period will be given to the subjects who require them. During the resting period and also the period where subjects are not required to participate, a chair will be provided for the subject to sit and rest.
The session will be conducted under the supervision/assistance of senior physiotherapist, research assistants and engineering group. Clinical symptoms/adverse clinical developments will be closely monitored.
Outcomes will be measured before (T0), immediately after (T1) and 1 month after the end of treatment (T2) of 6 weeks therapy session by an independent senior physiotherapist to ensure blinding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CT, Control Group
Conventional Gait Training
Conventional Gait Training
Subjects allocated to the CT group will first perform active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. They will then perform conventional gait and balance therapy based on the proprioceptive neuromuscular facilitation (PNF) concept for 15 minutes. They will be given a 5 minutes rest. Finally, the CT subjects will undergo the over-ground gait training with or without aid or orthoses and with manual assistance from senior physiotherapist for 15 minutes, depending on the individual subject's abilities.
WT, Experimental Group
Gait rehabilitation with walker
Gait rehabilitation with walker
For WT group, subjects will first go through active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. The main therapy consists of 2 parts with 5 minutes rest in between. During part 1, subjects will be trained on the robotic walker with the help of active body weight support (BWS) and functional electrical stimulation (FES) for 15 minutes with pelvic motion support function and lateral balance function being continuously provided. During part 2, subjects will also receive resistance/assistance forces on top of the BWS and FES training for 15 minutes.
Interventions
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Conventional Gait Training
Subjects allocated to the CT group will first perform active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. They will then perform conventional gait and balance therapy based on the proprioceptive neuromuscular facilitation (PNF) concept for 15 minutes. They will be given a 5 minutes rest. Finally, the CT subjects will undergo the over-ground gait training with or without aid or orthoses and with manual assistance from senior physiotherapist for 15 minutes, depending on the individual subject's abilities.
Gait rehabilitation with walker
For WT group, subjects will first go through active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. The main therapy consists of 2 parts with 5 minutes rest in between. During part 1, subjects will be trained on the robotic walker with the help of active body weight support (BWS) and functional electrical stimulation (FES) for 15 minutes with pelvic motion support function and lateral balance function being continuously provided. During part 2, subjects will also receive resistance/assistance forces on top of the BWS and FES training for 15 minutes.
Eligibility Criteria
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Inclusion Criteria
* More than 6 months from first ever stroke but within 5 years confirmed by CT or MRI Brain
* Mild to severe unilateral motor weakness (hemiparesis has to be severe with lower extremity strength graded as 3 or less on the Medical Research Council scale in more than 2 muscle groups) and severity should be between 5 and 25 calculated according to National Institute of Health Stroke Scale
* Significant gait deficits ( Functional Ambulation Category , FAC ≤ 4 )
* Able to understand instructions and participate in rehabilitation
* Spasticity: Modified Ashworth Scale (MAS) less than 4
* Independent trunk control
* Comfortable to walk without a walking aid
Exclusion Criteria
* Multiple stroke
* Intracranial bleeds
* Any chronic disabling pathologies
* Spasticity limiting lower extremity ROM to less than 80 %
* Mini Mental State Examination (MMSE) score \< 24
* Significant sensory deficit/ hemisensory neglect
* Any recent surgeries including orthopedic
* Active cancers or any other terminal illness
* Significant orthostatic hypotension
* Hip, knee and ankle arthrodesis
* Severe vascular disorders in lower limbs
* Having permanent pacemakers or ventriculoperitoneal shunt
* Subject's weight \> 75kg
50 Years
90 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Santhosh Kumar Seetharaman
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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Schmidt H, Sorowka D, Hesse S, Bernhardt R. [Development of a robotic walking simulator for gait rehabilitation]. Biomed Tech (Berl). 2003 Oct;48(10):281-6. doi: 10.1515/bmte.2003.48.10.281. German.
Patton J, Brown DA, Peshkin M, Santos-Munne JJ, Makhlin A, Lewis E, Colgate EJ, Schwandt D. KineAssist: design and development of a robotic overground gait and balance therapy device. Top Stroke Rehabil. 2008 Mar-Apr;15(2):131-9. doi: 10.1310/tsr1502-131.
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.
Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
Mayo NE, Wood-Dauphinee S, Ahmed S, Gordon C, Higgins J, McEwen S, Salbach N. Disablement following stroke. Disabil Rehabil. 1999 May-Jun;21(5-6):258-68. doi: 10.1080/096382899297684.
Forster A, Young J. Incidence and consequences of falls due to stroke: a systematic inquiry. BMJ. 1995 Jul 8;311(6997):83-6. doi: 10.1136/bmj.311.6997.83.
Daly JJ, Zimbelman J, Roenigk KL, McCabe JP, Rogers JM, Butler K, Burdsall R, Holcomb JP, Marsolais EB, Ruff RL. Recovery of coordinated gait: randomized controlled stroke trial of functional electrical stimulation (FES) versus no FES, with weight-supported treadmill and over-ground training. Neurorehabil Neural Repair. 2011 Sep;25(7):588-96. doi: 10.1177/1545968311400092. Epub 2011 Apr 22.
Scheidt RA, Stoeckmann T. Reach adaptation and final position control amid environmental uncertainty after stroke. J Neurophysiol. 2007 Apr;97(4):2824-36. doi: 10.1152/jn.00870.2006. Epub 2007 Jan 31.
Patton JL, Stoykov ME, Kovic M, Mussa-Ivaldi FA. Evaluation of robotic training forces that either enhance or reduce error in chronic hemiparetic stroke survivors. Exp Brain Res. 2006 Jan;168(3):368-83. doi: 10.1007/s00221-005-0097-8. Epub 2005 Oct 26.
Kao PC, Srivastava S, Agrawal SK, Scholz JP. Effect of robotic performance-based error-augmentation versus error-reduction training on the gait of healthy individuals. Gait Posture. 2013 Jan;37(1):113-20. doi: 10.1016/j.gaitpost.2012.06.025. Epub 2012 Jul 24.
Other Identifiers
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DSRB 2017/00696
Identifier Type: -
Identifier Source: org_study_id
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