NCT06130839

Brief Summary

This study compares two approaches for rehabilitating stroke patients: Perturbation-Based Training and Bobath-Based Trunk Exercises. The perturbation based training focuses on challenging patients with unexpected movements to improve their balance and stability. While the Bobath method, concentrating on facilitating normal movement patterns. The study aims to determine which approach yields better outcomes in terms of trunk control, balance, and functional recovery for stroke patients. 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
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 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

November 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

November 9, 2023

Last Update Submit

April 7, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Trunk Impairment Scale

    It is used to measure motor impairment of the trunk after stroke. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance "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. scoring criteria \< 10 seconds = normal. \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid. \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid. "Change will be measured from Baseline to 6 weeks"

    6 weeks

  • Postural Assessment Scale for Stroke Patient

    It is used for the assessments of postural control in stroke patients. It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36. "Change will be measured from Baseline to 6 weeks"

    6 weeks

  • Functional Gait Assessment

    It is for assessment of postural stability during walk. 3 Normal is able to ambulate for 10 steps heel to toe with no staggering. 2 Mild impairment, ambulates 7-9 steps. 1 Moderate impairment, ambulates 4-7 steps. 0 Severe impairment, ambulates less than 4 steps heel to toe or cannot perform without assistance. "Change will be measured from Baseline to 6 weeks"

    6 weeks

Secondary Outcomes (1)

  • Stroke Self-Efficacy Questionnaire

    6 weeks

Study Arms (2)

perturbation based training

EXPERIMENTAL

1. Stretching of the erector spinae, 2. latissimus dorsi, gluteus Medius, gluteus minimums, and gluteus maximus (knee to chest) Pelvic Bridging Exercises 3. Strengthening Exercises of latissimus dorsi muscle 4. Pelvic Bridging Exercises include the gluteus maximus and quadriceps 5. Rocker board: 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

bobath based training

EXPERIMENTAL

1. Stretching of the latissimus dorsi muscle 2. Functional use and strengthening of the latissimus dorsi. 3. Functional strengthening of abdominal and oblique abdominal muscles 4. Placing exercises to facilitate trunk extension 5. Rotations and counter-rotations (right and left) of the hips with the trunk extended Training of lumbar spine stabilizers Functional reach of shoulder, anterior, right, and left sides.

Other: Stable surface training

Interventions

Then intervention will be applied to the perturbation group as mention below at Rocker board (50 x 45 cm).the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after8th week (pre, mid and post intervention). 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.

Also known as: Experimental group
perturbation based training

the group will perform 36 sessions (4 times per week over 8 weeks) and effects of interventions will be measured before treatment, at 4th and after 8th week (pre, mid and post intervention).

Also known as: Experimental group
bobath based training

Eligibility Criteria

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

You may qualify if:

  • Able to walk with or without ambulatory aids
  • Able to follow commands.
  • Patients in the subacute and chronic stages associated with stroke hemiparesis (time since
  • stroke onset 6 months- 1 year)
  • Scoring \> 21 on MMSE

You may not qualify if:

  • Patients who have severe limitations in passive range of motion at lower extremities
  • Visual and sensory deficits
  • Patient who has contracture
  • Orthopedic or any other neurological disorder which impair balance.
  • Patients undergoing any other balance training protocol.
  • Patients with recurrent strokes
  • Participants who are currently participating in another clinical trial or research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LGH

Lahore, Punjab Province, 54400, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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 recieve.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

November 10, 2023

Primary Completion

April 10, 2024

Study Completion

April 10, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations