Development and Evaluation of a Novel Portable Robotic Gait Rehabilitation in Chronic Stroke

NCT03444688 | Unknown

• 1 other identifier: DSRB 2017/00696
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study is to test the training effects of the robotic walker. This study will compare the effectiveness of 2 different types of gait training protocols in chronic stroke patients, 1) conventional gait training (CT, control group), and 2) gait rehabilitation with the new walker modified after 1st stage (WT, experimental group).

Conditions

Stroke

Keywords

Robotic Walker

Outcome Measures

Primary Outcomes (11)

• Modified Ashworth Scale (MAS)

  Modified Ashworth Scale (MAS) measures resistance during passive soft-tissue stretching. It is a quick and easy measure that can help assess the efficacy of treatment. MAS is performed in the supine position (this will garner the most accurate and the lowest score as any tension anywhere in the body will increase spasticity). Scoring 0 = Normal tone, no increase in tone 1 = Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the range of motion (ROM) 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 ROM 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 = Considerable increase in muscle tone, passive movement difficult 4 = Affected part(s) rigid in flexion or extension

  3 minutes

• Medical Research Council (MRC) grading

  The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  5 minutes

• Functional Ambulation Category (FAC)

  FAC is a functional walking test that evaluates ambulation ability.

  2 minutes

• National Institute of Health Stroke Scale (NIHSS)

  NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  12 minutes

• Timed Up and Go (TUG)

  TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance.

  8 minutes

• Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. Description: 14-item scale designed to measure balance of the older adult in a clinical setting. Equipment needed: Ruler, two standard chairs (one with arm rests, one without), footstool or step, stopwatch or wristwatch, 15 ft walkway Completion: Time: 15-20 minutes Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk A change of 8 points is required to reveal a genuine change in function between 2 assessments.

  15 minutes

• Clinical Outcomes Variables Score (COVS)

  The COVS assesses functional mobility across a broad range of neurologic conditions.

  20 minutes

• 6 minute walk test

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  6 minutes

• Temporal spatial gait analysis (Part 1)

  Gait analysis is assessed by Tekscan Strideway which can provide temporospatial parameters including step length (cm), step width (cm), step time (s), step velocity (cm/s) and stride length (cm).

  10 minutes

• Temporal spatial gait analysis (Part 2)

  Gait analysis is assessed by Tekscan Strideway which can provide temporospatial parameters including stride time (s), gait cycle time (s), stance time (s), swing time (s), single support time (s), and double support time (s).

  10 minutes

• Electromyography (EMG)

  Electromyography (EMG) is evaluated by Delsys Trigno Wireless System which is a non-invasive method to detect muscle activity in mircoamperes. EMG sensors will be placed on Rectus Femoris, Tibilatis Anterior, Biceps Femoris, and lateral Gastrocnemius.

  10 minutes

Secondary Outcomes (4)

• Functional Independence Measure (FIM)

  8 minutes

• Revised Nottingham Sensory Assessment (rNSA)

  15 minutes

• Number of falls

  1 year

• Patient's attitudes towards the robotic walker using visual analogue scale (EQ-5D VAS) ranging from 0 (negative) to 10 (positive).

  5 minutes

Study Arms (2)

CT, Control Group

ACTIVE COMPARATOR

Conventional Gait Training

Other: Conventional Gait Training

WT, Experimental Group

EXPERIMENTAL

Gait rehabilitation with walker

Device: Gait rehabilitation with walker

Interventions

Conventional Gait Training OTHER

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.

CT, Control Group

Gait rehabilitation with walker DEVICE

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.

WT, Experimental Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is aged 50 years to 90 years old
• 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

You may not qualify if:

• Patient undergoing any formal rehabilitation program
• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (10)

• 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.

  PMID: 14606269 BACKGROUND

• 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.

  PMID: 18430678 BACKGROUND

• 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.

  PMID: 18467648 BACKGROUND

• 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.

  PMID: 17876068 BACKGROUND

• 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.

  PMID: 10381238 BACKGROUND

• 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.

  PMID: 7613406 BACKGROUND

• 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.

  PMID: 21515871 BACKGROUND

• 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.

  PMID: 17267755 BACKGROUND

• 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.

  PMID: 16249912 BACKGROUND

• 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.

  PMID: 22832470 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Walkers

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Santhosh Kumar Seetharaman

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santhosh Kumar Seetharaman

CONTACT

+65 6779 5555; mdcsnks@nus.edu.sg

Aileen Pang

CONTACT

+65 6601 3288; aileen_pang@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The recruited subjects will be divided into 2 groups through a simple randomization scheme using Microsoft Excel ("rand function"); 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.

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 23, 2018
• Study Start: April 2, 2018
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)