NCT05708378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

January 22, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Rocker board training, postural stability, balance, gait

Outcome Measures

Primary Outcomes (6)

  • Beg Balance Scale

    It is used to assess balance. , "Change will be measured from Baseline to 6 weeks"

    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"

    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"

    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"

    6 weeks

  • Functional Gait Assessment

    It is for assessment of postural stability during walk. "Change will be measured from Baseline to 6 weeks"

    6 weeks

  • Timed Walking Test

    It is used for assessing functional status or fitness. "Change will be measured from Baseline to 6 weeks"

    6 weeks

Secondary Outcomes (1)

  • Stroke Self-Efficacy Questionnaire

    6 weeks

Study Arms (2)

Rocker board training

EXPERIMENTAL

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.

Other: Rocker board training

Stable surface training

OTHER

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.

Other: Stable surface training

Interventions

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.

Also known as: Experimental group
Rocker board training

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.

Also known as: Control group
Stable surface training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • ● Any other neurological deficits as multiple sclerosis, Parkinsons disease etc.
  • Any musculoskeletal disorders like OA, ligament injury etc.
  • Non-ambulatory patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinnar Hospital

Abbottabad, Khyber Pakhtunkhwa, 22020, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Aruba Saeed, PhD*

    Riphah International University Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participants and outcome assessors will be kept blinded about the intervention which the patients will be going to receive
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 1, 2023

Study Start

June 10, 2023

Primary Completion

October 30, 2023

Study Completion

November 30, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations