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The Effect of Multi-sensorimotor training on proprioception and balance in stroke patients

Status Approved

  • First Submitted Date

    2018/07/04

  • Registered Date

    2018/08/17

  • Last Updated Date

    2018/08/14

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003097
    Unique Protocol ID 1044396-201803-HR-068-01
    Public/Brief Title The Effect of Multi-sensorimotor training on proprioception and balance in stroke patients
    Scientific Title The Effect of Multi-sensorimotor training on proprioception and balance in stroke patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1044396-201803-HR-068-01
    Approval Date 2018-03-27
    Institutional Review Board Name Gachon University Institutional Review Board
    Institutional Review Board Address 1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-750-8566
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Chaegil Lim
    Title associate prof.
    Telephone +82-32-820-4424
    Affiliation Gachon University
    Address 191 Hambangmoe-ro, Yeonsu-gu,Incheon, 21936,South Korea.
    Contact Person for Public Queries
    Name Chaegil Lim
    Title associate prof.
    Telephone +82-32-820-4424
    Affiliation Gachon University
    Address 191 Hambangmoe-ro, Yeonsu-gu,Incheon, 21936,South Korea.
    Contact Person for Updating Information
    Name Chaegil Lim
    Title associate prof.
    Telephone +82-32-820-4424
    Affiliation Gachon University
    Address 191 Hambangmoe-ro, Yeonsu-gu,Incheon, 21936,South Korea.
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2018-03-27 Actual
    Target Number of Participant 42
    Primary Completion Date 2018-05-25 , Actual
    Study Completion Date 2018-05-27 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Incheon Redcross Hospital
    Recruitment Status Completed
    Date of First Enrollment 2018-03-27 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Gachon University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gachon University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Impaired sensory and functional balance ability following strokes often has negative impacts on patients, their family, and society. 
    About 50% of stroke patients experience sensory impairment. Occasionally, this impairment may be accompanied by neurological disorders, including hemianopsia, aphasia, or hemispatial neglect. In >50% of cases, sensory disorders include the face, arm, trunk, and leg of the affected side. Sixty-five percent of stroke patients experience impaired tactile and protective responses, including proprioceptive sensations. As a result, stroke patients are less able to transmit information to the brain and spinal cord regarding muscle strength, pressure, joint position, and muscle length, which are required to maintain posture and can be detected in various joints on the paralyzed side. 
    Stroke survivors typically have decelerated and impaired balance reactions, poorer body weight support on the affected limb, and excessive postural sway. Balance impairment ranks first among stroke disorders. Reduced muscle force and range of motion, impaired motor coordination, and sensory organization issues emerging after a stroke impair the maintenance of balance. Impaired balance not only increases the risk of falls and social isolation, but also negatively affects physical activity.
    In general, repetitive sensory stimulation and mass motor or task practice facilitate neuroplasticity and brain reorganization in stroke patients, resulting in enhanced motor and functional recovery after stroke. These rehabilitative programs can be categorized into the following two main groups according to theoretical backgrounds of clinical trials: conventional and advanced rehabilitation programs. Conventional rehabilitation programs address the effectiveness of treatment approaches based on neurophysiological, motor control and learning, or strengthening and functional principles. 
    Conventional rehabilitation programs include the Bobath (also called Neurodevelopmental Treatment), Brunnstrom, proprioceptive neuromuscular facilitation (PNF), and functional strengthening approaches, as regular therapies apply sensory input with visual, verbal, tactile, cutaneous, proprioceptive, and auditory assistance in clinical stroke rehabilitation. Advanced rehabilitation programs include electrical stimulation, Robotic therapy, virtual reality, etc. to input proprioceptive, tactile, visual, and auditory help, and emphasize the effectiveness of specific interventions based on neuro-scientific evidence. Previous researchers have recommended trunk-targeted training on a vibration board and reactive balance training through perturbation, which are types of sensorimotor training, as described by Janda. Sensorimotor training includes passive and active facilitation of afferents that have a strong impact on posture control and equilibrium, which is effective for facilitation of the muscle spindle.
    Recently, according to the patient’s mobility status and recovery phase, the appropriate advanced rehabilitation therapy combined with conventional rehabilitation treatment comprise of sensorimotor training. This combined sensorimotor training may provide multiple sensory inputs for therapists to maximize the recovery of stroke patients. However, to our knowledge, it is rare that previous studies have targeted multi-sensory input training in stroke patients. 
    Thus, the purpose of the current study was to examine the effect of multi-sensory input training on proprioception and balance in stroke patients.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Others (Two-group pretest-posttest study)
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Caregiver
    Allocation RCT
    Intervention Type Others (conventional physical therapy/tradmill training/multi-sensorimotor training)
    Intervention Description
    Thirty subjects who experienced stroke participated in this study and were randomly assigned into two groups: the multi-sensorimotor training group (n=21) and the treadmill training group (n=21). Both groups first performed conventional physical therapy for 30 min, after which the multi-sensorimotor training group performed multi-sensorimotor training for 30 min, and the treadmill training group performed treadmill gait training for 30 min. Both groups performed the therapeutic interventions 5 days per week for 8 weeks.
    Number of Arms 2
    Arm 1

    Arm Label

    the tradmill training group

    Target Number of Participant

    21

    Arm Type

    Active comparator

    Arm Description

    The treadmill group underwent treadmill gait training with a Placebo TENS for 30 min in the paralyzed medial and lateral bellies of the gastrocnemius muscle. Subjects participated 5 days per week for 8 weeks. Training started with 10-20 min at low intensity (40-50% heart rate reserve [HRR]). The duration progressed 5 min every 2 weeks and the intensity progressed 5 percent HRR every 2 weeks, with a goal of 30 min at 60-70% HRR.
    Arm 2

    Arm Label

    The multi-sensorimotor training group

    Target Number of Participant

    21

    Arm Type

    Experimental

    Arm Description

    The multi-sensorimotor training program included the Stabilize-T and Reha-Bar (Pedalo®) exercises with TENS. The electrical stimulation (bipolar-balanced stimuli, pulse width of 200 μs, frequency of 100 Hz) was delivered by a dual-channel commercial TENS unit (TENS 7000TM, Koalaty Products Inc, USA) and adhesive TENS electrodes (5 cm2) were fastened to the skin overlying the paralyzed medial and lateral bellies of the gastrocnemius muscles. In conditions involving stimulation, the TENS amplitude was adjusted before the start of measurements in increments of 0.01 mA and set at the sensory detection threshold of each subject. Stabilizer T is a piece of equipment that trains an individual to improve sensory (proprioceptive and tactile) control of their posture and movements as well as the reaction and stabilization of their locomotor system. The platform can either be mounted on springs (three-dimensional effect) or suspended from ropes (two-dimensional effect). 
    Exercise methods: (i) Subjects looked straight ahead while standing with their knee slightly bent on the Stabilize-T. They closed their eyes for 15 s, subsequently opened their eyes for 10 s, then maintained balance for 30 s. After subjects stood on the Reha-bar, they pedaled up and down and rotated the wheels to move forward while holding the safety bar with both hands with the therapist’s assistance. (ii) Subjects looked straight ahead while standing with their knee slightly bent on the Stabilize-T. They abducted their arms and slowly rotated their neck to the left, center, and right for 30 s each, and maintained balance for 30 s. After subjects stood on the Reha-bar, they pedaled up and down and rotated the wheels to move forward while holding the safety bar with both hands without assistance by the therapist. (ii) Subjects looked straight ahead while standing with their knee slightly bent on the Stabilize-T. They abducted their arms and extended their neck for 10 s. Subjects repeated the neck extension 3 times and afterward they maintained balance for 30 s. After subjects stood on the Reha-bar, they pedaled up and down and rotated the wheels to move forward and backward with holding the safety bar with both hands without assistance by the therapist. Number one was the easiest and number three was the hardest. We applied one of these methods to the patients considering their ability. These exercise methods were provided by a previous study.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    47Year~71Year

    Description

    Subjects who were diagnosed with first onset of unilateral hemisphere stroke ≥6 months previously, could walk for ≥30 s (regardless of using an assistive device), and had a mini-mental state examination Korean version (MMSE-K) score of ≥24 were enrolled.
    Exclusion Criteria
    Exclusion criteria consisted of the presence of a cognitive disorder, visual disorder, cardiorespiratory disorder (with cardiac pacemaker), orthopedic intervention, and those receiving botulinum toxin injections within the past year.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Balance test
    Timepoint
    pretest-posttest
    Primary Outcome(s) 2
    Outcome
    Proprioception test
    Timepoint
    pretest-posttest
    Secondary Outcome(s) 1
    Outcome
    gait ability
    Timepoint
    pretest-posttest
    Secondary Outcome(s) 2
    Outcome
    fall risk
    Timepoint
    pretest-posttest
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 30
    Number of Publication 0
    Results Upload Effect_of_Multi_Lim_20180605_1.docx
    Date of Posting Results 2018/08/17
    Protocol URL or File Upload
    Brief Summary
    This study provides evidence that combined rehabilitation methods significantly enhance the proprioception and balance ability during the chronic phase of recovery from stroke. Therapists play an important role in achieving the maximum benefit through an entire rehabilitation process, from acute to subacute and to the chronic status of stroke. They have systematically evaluated the optimal intensity and duration of specific interventions. Therefore, combining valuable trainings to input multiple senses is believed to be a good method to facilitate the restoration of proprioception and balance ability.
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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