The Effects of Reaching Task Following Selective Trunk Stability Exercise

Sponsor
University of Valencia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767437
Collaborator
Ulsan National Institute of Science and Technology (Other)
40
1
2
11
3.6

Study Details

Study Description

Brief Summary

This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Abdominal drawing-in maneuver exercise
  • Behavioral: sham
N/A

Detailed Description

All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are

Abdominal drawing-in maneuver exercise is following as:

It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.

Conventional physiotherapy is following as:

Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.

On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind.
Primary Purpose:
Treatment
Official Title:
The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors
Actual Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
May 10, 2023
Anticipated Study Completion Date :
Jul 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)

Participants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes.

Behavioral: Abdominal drawing-in maneuver exercise
From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
Other Names:
  • Stabilizer pressure biofeedback
  • Behavioral: sham
    Release pain or upper limb mobilization
    Other Names:
  • Conventional therapy
  • Experimental: Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

    Participants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy

    Behavioral: Abdominal drawing-in maneuver exercise
    From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
    Other Names:
  • Stabilizer pressure biofeedback
  • Behavioral: sham
    Release pain or upper limb mobilization
    Other Names:
  • Conventional therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in compensatory trunk dislocation at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Dislocation distance in millimeters(mm) for reaching phase

    2. Change from baseline in smoothness movement at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Number of movement units for reaching phase

    3. Change from baseline in elbow angle at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Elbow angle in degree for reaching phase -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.

    Secondary Outcome Measures

    1. Change from baseline in reaching time at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Duration of time in second(s) for reaching phase

    2. Change from baseline in peak velocity at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Hand distance and duration of time are combined in mm/s for reaching phase

    3. Change from baseline in elbow angular velocity at 4weeks [Baseline, two period(each 4weeks), wash out(4weeks)]

      Change in elbow angle and time rate are combined in rad/s for reaching phase

    Other Outcome Measures

    1. Modified Ashworth Scale(MAS)_Stiffness of chronic stroke [Baseline]

      Scoring for Biceps and Triceps MAS 0: No increase in tone MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension. MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed MAS 3: considerable increase in tone, passive movement difficult MAS 4: limb rigid in flexion or extension

    2. Range of motion_Health status chronic stroke [Baseline]

      Shoulder and elbow joint range of motion Shoulder: flexion, adduction, abduction, external rotation, internal rotation Elbow: flexion, extension

    3. Trunk impairment scale(TIS)_Health status chronic stroke [Baseline]

      The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance. Static sitting balance Dynamic sitting balance Coordination Total score is 23 points

    4. Postural assessment scale for stroke(PASS)_Health status chronic stroke [Baseline]

      -Maintaining posture Sitting without support Standing with support Standing without support Standing on non paretic leg Standing on paretic leg -Changing a posture Supine to paretic side lateral Supine to non-paretic side lateral Supine to sitting up on the edge mat Sitting on the edge of mat to supine Sitting to standing up Standing up to sitting down Standing, picking up a pencil from the floor Total scoring ranges from 0 to 36

    5. Fugl Meyer Assessment(FMA)_Health status chronic stroke [Baseline]

      Upper extremity(UE) Commonly used FMA-UE cutoff scores defined each category: 0 to 20 severe, 21 to 50 moderate, and 51 to 66 mild. Shoulder, Elbow and Forearm Reflex activity Volitional movement within synergies Volitional movement mixing synergies Volitional movement with little or no synergy Normal reflex activity Wrist Hand Coordination/Speed Total score is 66 points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The subject consisted of the physician's confirmation of chronic hemiplegia

    • onset ≥ 6 months

    • Mini-mental state examination≥25

    • Biceps ≤2, Triceps≤2

    • Ability to Sit on a chair alone

    • FMA UE score ≥ 21points, FMA UE≤ 66 points

    Exclusion Criteria:
    • Biceps>2, Triceps>2

    • Flaccid

    • Neglect syndrome

    • Have neurological disease and orthopedic disease

    • Lack of coordination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ulsan National Institute of Science and Technology Ulsan Ulju Korea, Republic of 44919

    Sponsors and Collaborators

    • University of Valencia
    • Ulsan National Institute of Science and Technology

    Investigators

    • Principal Investigator: Jóse Casaña Granell, PhD, University of Valencia
    • Principal Investigator: Joaquin Calatayud Villalba, PhD, University of Valencia
    • Principal Investigator: Sang Hoon Kang, PhD, Ulsan National Institute of Science&Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Valencia
    ClinicalTrials.gov Identifier:
    NCT05767437
    Other Study ID Numbers:
    • ADIM exercise
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Valencia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 14, 2023