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Comparison of Rocker Board and Stable Surface Training on Postural Stability, Balance and Gait (ACAMCAOAMMSE)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Rocker board training
Stable surface training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rocker board training, postural stability, balance, gait

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both genders Age: between 40-60 years. Unilateral hemiplegia. ACA and MCA lesions only. Subacute and chronic stroke patients. First time affected. No visual and sensory deficits. Ambulatory stroke patients scoring 21 to 40 on Berg Balance Scale. Scoring > 21 on MMSE. Exclusion Criteria: ● Any other neurological deficits as multiple sclerosis, Parkinsons disease etc. Any musculoskeletal disorders like OA, ligament injury etc. Non-ambulatory patients

Sites / Locations

  • Chinnar HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Rocker board training

Stable surface training

Arm Description

Stretching Exercises (Heel drop, heel raises, Hamstring stretch, quad stretch, half kneel, IT band stretch, half squats). Hold the stretch for 20 seconds and repeat 10 times. Isometric Strengthening Exercises of calves, hamstrings, quads, hip flexors, gluteus, dorsiflexors and plantarflexors. Hold for 20 seconds and repeat 10 times. Pelvic Bridging Exercises. Trunk control exercises on Rocker Board in standing position first in medio-lateral direction for 10 min and then in anterio-posterior direction for 10 min with breaks in between.

Stretching Exercises (Heel drop, heel raises, Hamstring stretch, quad stretch, half kneel, IT band stretch, half squats). Hold the stretch for 20 seconds and repeat 10 times. Strengthening Exercises calves, hamstrings, quads, hip flexors, gluteus, dorsiflexors and plantarflexors. Hold for 20 seconds and repeat 10 times. Pelvic Bridging Exercises. Trunk balance exercise (flexion, extension of lower and upper trunk, rotation of lower and upper trunk, forward and lateral reach) on plain surface.

Outcomes

Primary Outcome Measures

Beg Balance Scale
It is used to assess balance. , "Change will be measured from Baseline to 6 weeks"
Trunk Impairment Scale
It is used to measure motor impairment of the trunk after stroke. "Change will be measured from Baseline to 6 weeks"
Postural Assessment Scale for Stroke Patients
It is used for the assessments of postural control in stroke patients. "Change will be measured from Baseline to 6 weeks"
Timed Up and Go Test
It is for the assessment of lower extremity function, mobility and fall risk. "Change will be measured from Baseline to 6 weeks"
Functional Gait Assessment
It is for assessment of postural stability during walk. "Change will be measured from Baseline to 6 weeks"
Timed Walking Test
It is used for assessing functional status or fitness. "Change will be measured from Baseline to 6 weeks"

Secondary Outcome Measures

Stroke Self-Efficacy Questionnaire
It evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. "Change will be measured from Baseline to 6 weeks"

Full Information

First Posted
January 22, 2023
Last Updated
July 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05708378
Brief Title
Comparison of Rocker Board and Stable Surface Training on Postural Stability, Balance and Gait
Acronym
ACAMCAOAMMSE
Official Title
Comparison of Rocker Board and Stable Surface Training on Postural Stability, Balance and Gait in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is limited literature for the evaluation of comparison between effectiveness of postural control and balance training program on stable surface and unstable surface. So this study will help to improve reactive postural control in stroke patients which ultimately improve their walking capability, mobility and level of independence. This study will also enable the individual to be more independent and minimize their falls.
Detailed Description
Stroke is the second cause of death and the third cause of disability worldwide. It leads towards severe disability having a great impact upon independent activities of daily living. Postural stability and balance is often affected by strokes. Balance is a complex function with dynamic and static components. It is a major determinant of community ambulation and gait performance following strokes. Falls in post-stroke patients commonly occur due to impairment of balance. Hence, one of the primary objectives in stroke rehabilitation is to restore postural stability and functional balance, which is a combination of dynamic, static and reactive balance. For improving postural stability and balance one such technique is the utilization of a rocker board, where a platform positioned on an unstable surface is used to challenge balance. Whilst rocker boards have been used effectively for, postural stability, injury prevention, rehabilitation and balance enhancement. Improvements in rocker board performance may be attributable to one or more of the following: muscle strengthening, enhanced intersegmental coordination, increase in brain activity in the supplementary motor area and/or enhanced feed-forward and feed-backward postural control mechanisms. Postural instability limits lower limb functional activities, hence; rapid and optimal improvement of postural control in stroke patients is essential for their independence, social participation and general health. Improvement in postural stability have a great impact upon balance and gait. Rocker board training is also effective for gait and trunk balance in stroke patients. Postural stability increases due to unstable surface because perturbations felt by patients and consequent trails to compensate while doing exercises on the tilted Rocker Board activate the motor system of the patients. Neural plasticity may be enhanced by regular and repeated administration of this training. The trunk exercises on an unstable surface sensitize the muscle spindle through gamma motor neurons, thereby improving motor output which influences the stability of joint. Exercises on an unstable surface increases the external swing which more effectively encourages postural orientation by forcing faster modifications of the sensory and motor systems and also assists in the postural strategy of self-postural control. The trunk stabilization in stroke patients in an important prognostic factor of the recovery of balance ability and functional ambulation. The gait and balance improvement is because the motor cortex precedes from proximal to distal, the improved level of proximal trunk control leads to improvement in distal lower limb control which helped in altering better balance and gait. The relationship between postural control and improved mobility is already established. Through this study we want to improve postural stability through rocker based training and ultimately patient's dynamic balance and gait so functional capability of stroke patients can be enhanced.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rocker board training, postural stability, balance, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
participants and outcome assessors will be kept blinded about the intervention which the patients will be going to receive
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocker board training
Arm Type
Experimental
Arm Description
Stretching Exercises (Heel drop, heel raises, Hamstring stretch, quad stretch, half kneel, IT band stretch, half squats). Hold the stretch for 20 seconds and repeat 10 times. Isometric Strengthening Exercises of calves, hamstrings, quads, hip flexors, gluteus, dorsiflexors and plantarflexors. Hold for 20 seconds and repeat 10 times. Pelvic Bridging Exercises. Trunk control exercises on Rocker Board in standing position first in medio-lateral direction for 10 min and then in anterio-posterior direction for 10 min with breaks in between.
Arm Title
Stable surface training
Arm Type
Other
Arm Description
Stretching Exercises (Heel drop, heel raises, Hamstring stretch, quad stretch, half kneel, IT band stretch, half squats). Hold the stretch for 20 seconds and repeat 10 times. Strengthening Exercises calves, hamstrings, quads, hip flexors, gluteus, dorsiflexors and plantarflexors. Hold for 20 seconds and repeat 10 times. Pelvic Bridging Exercises. Trunk balance exercise (flexion, extension of lower and upper trunk, rotation of lower and upper trunk, forward and lateral reach) on plain surface.
Intervention Type
Other
Intervention Name(s)
Rocker board training
Other Intervention Name(s)
Experimental group
Intervention Description
Patients will perform 24 sessions (4 times per week over 6 weeks) and effects will be measured before treatment, at 3rd and after 6th week.
Intervention Type
Other
Intervention Name(s)
Stable surface training
Other Intervention Name(s)
Control group
Intervention Description
Patients will perform 24 sessions (4 times per week over 6 weeks) and effects will be measured before treatment, at 3rd and after 6th week.
Primary Outcome Measure Information:
Title
Beg Balance Scale
Description
It is used to assess balance. , "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Title
Trunk Impairment Scale
Description
It is used to measure motor impairment of the trunk after stroke. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Title
Postural Assessment Scale for Stroke Patients
Description
It is used for the assessments of postural control in stroke patients. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Title
Timed Up and Go Test
Description
It is for the assessment of lower extremity function, mobility and fall risk. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Title
Functional Gait Assessment
Description
It is for assessment of postural stability during walk. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Title
Timed Walking Test
Description
It is used for assessing functional status or fitness. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Stroke Self-Efficacy Questionnaire
Description
It evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. "Change will be measured from Baseline to 6 weeks"
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders Age: between 40-60 years. Unilateral hemiplegia. ACA and MCA lesions only. Subacute and chronic stroke patients. First time affected. No visual and sensory deficits. Ambulatory stroke patients scoring 21 to 40 on Berg Balance Scale. Scoring > 21 on MMSE. Exclusion Criteria: ● Any other neurological deficits as multiple sclerosis, Parkinsons disease etc. Any musculoskeletal disorders like OA, ligament injury etc. Non-ambulatory patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, PhD*
Organizational Affiliation
Riphah International University Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinnar Hospital
City
Abbottabad
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22020
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, PhD*
Phone
03344399403
Email
aruba.saeed@gmail.com
First Name & Middle Initial & Last Name & Degree
Zarafshann, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Rocker Board and Stable Surface Training on Postural Stability, Balance and Gait

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