NCT06476782

Brief Summary

The aim of the study is to determine combined effects of MRP and aerobic exercise in postural stability and lower limb function in subacute stroke patients

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 11, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Aerobic exerciseStrokeMRP

Outcome Measures

Primary Outcomes (2)

  • Postural assessment scale for e

    The postural assessment scale for stroke is an outcome measure specifically designed to assess and monitor postural control after stroke.The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36.The higher the score is, the more favourable the balance in stroke patients.

    8th week

  • Lower extremity functional scale

    LEF is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. LEFS is scored on a scale of 0 to 80, with higher scores indicating better lower limb function. The interpretation of the scores can be based on the following categories: 0-20: Severe functional limitation. 21-40: Moderate functional limitation.

    8th week

Study Arms (2)

Combined MRP and aerobic exercise

EXPERIMENTAL

Group A received MRP treatment and aerobic exercise along with conventional therapy

Other: Motor Relearning Program(MRP) and aerobic exercise

MRP group

EXPERIMENTAL

Group B received MRP treatment along with conventional therapy

Other: Motor Relearning Program(MRP)

Interventions

Participants of this group received training for a total of 8 weeks in the form of 3 sessions per week each session of 40 minutes, with a total of 24 sessions.

Combined MRP and aerobic exercise

the week 8 session was held in which patients were involved in 60-minute activities that involved practicing functional tasks without explicitly giving any type of relationship between those learned skills and the remedial tasks.

MRP group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female patients were included.
  • Stroke patients with age range 50-70 years
  • Stroke patients with no serious unstable medical complications.
  • Patients with ischemic stroke
  • Patients who can follow directions (written, verbal, demonstration)
  • Patients who were not receiving any other form of physiotherapy treatment.
  • Patients with cognition level of \>24 on MMSE scale
  • Stroke patients with 1 to 5 months of stroke history (Sub-Acute Stroke Patients)

You may not qualify if:

  • Patients with any cardiac problem
  • Patients with history of any other neurological disease other than stroke.
  • Patients with peripheral arterial occlusive disease
  • Patients with surgeries like amputations of lower limb
  • MAS score \> +3 were not included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islam Central Hospital , New life hospital

Sialkot, Punjab Province, 51040, Pakistan

RECRUITING

Related Publications (3)

  • Chen R, Zhang Y, Wang X, Zhao Y, Fan S, Xue Y, Zhao J, Liu Y, Wang P. Treatment effects of low-frequency repetitive transcranial magnetic stimulation combined with motor relearning procedure on spasticity and limb motor function in stroke patients. Front Neurol. 2023 Aug 11;14:1213624. doi: 10.3389/fneur.2023.1213624. eCollection 2023.

    PMID: 37638202BACKGROUND
  • Lee JI, Park J, Koo J, Son M, Hwang JH, Lee JY, Chang WH. Effects of the home-based exercise program with an augmented reality system on balance in patients with stroke: a randomized controlled trial. Disabil Rehabil. 2023 May;45(10):1705-1712. doi: 10.1080/09638288.2022.2074154. Epub 2022 May 15.

    PMID: 35574910BACKGROUND
  • Marzolini S, Brooks D, Oh P, Jagroop D, MacIntosh BJ, Anderson ND, Alter D, Corbett D. Aerobic With Resistance Training or Aerobic Training Alone Poststroke: A Secondary Analysis From a Randomized Clinical Trial. Neurorehabil Neural Repair. 2018 Mar;32(3):209-222. doi: 10.1177/1545968318765692. Epub 2018 Mar 30.

    PMID: 29600726BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aruba Saeed, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study will be single blinded as the assessor of study will be kept blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 26, 2024

Study Start

February 1, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations