NCT04820660

Brief Summary

Stroke is ranked as the number fifth cause of death and a main cause of disability in the United States. It affects the arteries which supply blood to and within the brain. If the blood supply to the brain is disrupted, it will not be able to receive oxygen and the nutrients which are transported by those arteries. This leads to the death of brain cells having a magnificent effect on the function of that part.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2019

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

March 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

Balanceprogressive resistance strength training

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.

    4months

  • Fugl Meyer Assessment Lower Extremity

    Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

    4 months

Study Arms (2)

Task oriented Strength training group

EXPERIMENTAL

Standing and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks

Other: Task orientated strengthening training

Balance Training

EXPERIMENTAL

Stepping forward, backward, and sideways on the exercise step; Stepping over blocks of various heights; Standing up from a chair, From a sitting position on a 65-cm Swiss ball, Arms; bending the trunk forward and side to side); Performing double-legged stance Performing tandem stance Rising from a chair without the use of the arms; Walking forward and backward with a tandem walking pattern Performing single- legged stance

Other: Balance training exercises

Interventions

1. Standing and reaching in different directions for objects located beyond arm's length to promote loading of the lower limbs and activation of lower limb muscles; 2. Sit-to-stand from various chair heights to strengthen the lower limb extensor muscles; 3. Stepping forward and backward onto blocks of various heights to strengthen the lower limb muscles; 4. Stepping sideways onto blocks of various heights to strengthen the lower limb muscles; 5. forward step-up onto blocks of various heights to strengthen the lower limb muscles; 6. heel(s) raise and lower while maintaining in a standing posture to strengthen the plantar- flexor muscles. Each workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy.

Task oriented Strength training group

1. Stepping forward, backward, and sideways on the exercise step; 2. Stepping over blocks of various heights; 3. Standing up from a chair, walking four steps forward, performing a bilateral stool touch and walking backwards to the chair; 4. Standing up from a chair, walking four steps forward, turning to the right, stepping over the exercise step, turning to the right again and walking forwards to the chair (repeat the exercise circuit in opposite direction); 5. From a sitting position on a 65-cm Swiss ball, performing a range of motion and balance exercises (forward and backward rolling of the 6. Arms; bending the trunk forward and side to side); 7. Performing double-legged stance for 10 s; 8. Performing tandem stance for 10 s; 9. Rising from a chair without the use of the arms; 10. Walking forward and backward with a tandem walking pattern (toes of one foot touching the heel of the foot in front); 11. Performing single- legged stance for 10 s.

Balance Training

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hemiparetic from a single stroke occurring at least a year earlier, not presently receiving any rehabilitation services,
  • Participants should not be receiving any rehabilitation services
  • Participants should be able to walk 10 m independently without an assistive device
  • Participants should be medically stable enough to allow participation, and able to understand instructions and follow commands.

You may not qualify if:

  • Participants with any medical condition that would prevent participation in the training program
  • Participants with any uncontrolled health condition for which exercise is contraindicated.
  • Participants with any tumor or neurological signs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah IU

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PMID: 21571152BACKGROUND
  • National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.

    PMID: 7477192BACKGROUND
  • van der Worp HB, van Gijn J. Clinical practice. Acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):572-9. doi: 10.1056/NEJMcp072057. No abstract available.

    PMID: 17687132BACKGROUND
  • Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009 Jun;40(6):2068-72. doi: 10.1161/STROKEAHA.108.540112. Epub 2009 Apr 9.

    PMID: 19359645BACKGROUND
  • Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.

    PMID: 12444191BACKGROUND
  • Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.

    PMID: 12855835BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rabiya Noor, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 29, 2021

Study Start

March 1, 2019

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations