NCT04752124

Brief Summary

Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen. The purpose of this study is to Determine the effect of high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

February 9, 2021

Last Update Submit

March 15, 2021

Conditions

Keywords

Cerebrovascular accidentAerobic exerciseHigh intensity interval training

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk test

    To determine the endurance after stroke

    6 weeks of training

Secondary Outcomes (2)

  • Berg Balance scale

    5 weeks

  • Stroke Impact scale

    5 weeks

Study Arms (2)

HIIT+CT

ACTIVE COMPARATOR

HIIT combined with conventional rehabilitation.

Other: Exercise TherapyOther: conventional therapy

Conventional therapy

PLACEBO COMPARATOR

Conventional rehabilitation will be provided to this group of patients.

Other: conventional therapy

Interventions

High intensity speed based interval treadmill training

HIIT+CT

conventional physical therapy

Conventional therapyHIIT+CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-80 years; first episode of stroke; \>4 weeks of stroke onset; hemiparesis resulting from unilateral ischaemic stroke; Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively; mini-mental state examination score ≥23; ability to perform independent walking for at least five minutes with or without an assistive device (FAC=3). All patients will be determined to be in stable cardiovascular condition with a low although slightly greater risk for vigorous exercise than for apparently healthy persons (class B according to the American College of Sports Medicine \[ACSM\]).13

You may not qualify if:

  • Participants will be excluded from the study if they had any of the following: (1) chronic cardiorespiratory or metabolic diseases; (2) severe osteoporosis; and (3) lesions pertaining to the brainstem or cerebellum; (4) having resting blood pressure above 160/100 mmHg even after taking medications; (5) cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardio-myopathy); (6) transient ischemic attack; (7) by-pass surgery in the recent three months; and (8) other musculoskeletal problems that prevented the participants from doing aerobic activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bin Inam Rehabilitation Center.

Faisalābad, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

  • Lau KW, Mak MK. Speed-dependent treadmill training is effective to improve gait and balance performance in patients with sub-acute stroke. J Rehabil Med. 2011 Jul;43(8):709-13. doi: 10.2340/16501977-0838.

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 12, 2021

Study Start

November 7, 2020

Primary Completion

February 27, 2021

Study Completion

March 15, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations