NCT04823546

Brief Summary

Stroke is a leading cause of disability worldwide affecting both male and female especially in older people. Functional independence and locomotion are hampered in stroke, therefore, affecting their quality of life. Objective: To find the comparative effects of activity base therapy vs strength training on gait performance in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 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

February 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

Activity based therapyChronic strokeGaitstrength trainingexercises

Outcome Measures

Primary Outcomes (2)

  • Time Up and Go Test (TUG)

    Simple screening test that is a sensitive and specific measure of probability for falls among older adultsThe Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

    2 months

  • Fugl meyer for lower limb

    The fugal-meyer assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning in patient with post stroke hemiplegia.

    2 months

Study Arms (2)

Activity based therapy

EXPERIMENTAL

Activity based training was done in 2 phases. exercise involve 1. Standing and reaching 2. Sit-to-stand 3. Stepping forward and backward Phase 2 Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill;

Other: activity based therapy

strength training

ACTIVE COMPARATOR

Strength training for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances

Other: Strength Training

Interventions

Standing and reaching (2) Sit-to-stand (3) Stepping forward and backward onto blocks (4) Stepping sideways onto blocks (5) Forward step up onto blocks (6) Raising and lowering of heel (7) Standing with the base of support constrained with feet in parallel and tandem conditions Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill; (11) Walking over various surfaces and obstacles;

Activity based therapy

Strength training included for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances

strength training

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were at least 6 months post stroke.
  • Ability to walk independent or with help of walking aids
  • Ischemic stroke patients included in study.
  • Mini mental state examination patients fully understand the commands

You may not qualify if:

  • Presence of orthopaedic problems.
  • Neurological disorders.
  • Psychological problems.
  • Cognitive issues.
  • People with severe visual issues.
  • Participants with other medical complications foot ulcers, orthopaedic or other neurological impedance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Saleh MSM, Rehab NI, Aly SMA. Effect of aquatic versus land motor dual task training on balance and gait of patients with chronic stroke: A randomized controlled trial. NeuroRehabilitation. 2019;44(4):485-492. doi: 10.3233/NRE-182636.

    PMID: 31256082BACKGROUND
  • Tisserand R, Armand S, Allali G, Schnider A, Baillieul S. Cognitive-motor dual-task interference modulates mediolateral dynamic stability during gait in post-stroke individuals. Hum Mov Sci. 2018 Apr;58:175-184. doi: 10.1016/j.humov.2018.01.012. Epub 2018 Mar 12.

    PMID: 29448162BACKGROUND
  • Park HK, Lee HJ, Lee SJ, Lee WH. Land-based and aquatic trunk exercise program improve trunk control, balance and activities of daily living ability in stroke: a randomized clinical trial. Eur J Phys Rehabil Med. 2019 Dec;55(6):687-694. doi: 10.23736/S1973-9087.18.05369-8. Epub 2018 Oct 29.

    PMID: 30370752BACKGROUND
  • Lund C, Dalgas U, Gronborg TK, Andersen H, Severinsen K, Riemenschneider M, Overgaard K. Balance and walking performance are improved after resistance and aerobic training in persons with chronic stroke. Disabil Rehabil. 2018 Oct;40(20):2408-2415. doi: 10.1080/09638288.2017.1336646. Epub 2017 Jun 9.

    PMID: 28597708BACKGROUND
  • Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019.

    PMID: 31317037BACKGROUND
  • Lamberti N, Straudi S, Malagoni AM, Argiro M, Felisatti M, Nardini E, Zambon C, Basaglia N, Manfredini F. Effects of low-intensity endurance and resistance training on mobility in chronic stroke survivors: a pilot randomized controlled study. Eur J Phys Rehabil Med. 2017 Apr;53(2):228-239. doi: 10.23736/S1973-9087.16.04322-7. Epub 2016 Sep 14.

    PMID: 27626795BACKGROUND
  • Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellstrom K. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial. Disabil Rehabil. 2017 Aug;39(16):1615-1622. doi: 10.1080/09638288.2016.1206631. Epub 2016 Jul 14.

    PMID: 27415645BACKGROUND
  • Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8.

    PMID: 26969343BACKGROUND
  • Chan K, Phadke CP, Stremler D, Suter L, Pauley T, Ismail F, Boulias C. The effect of water-based exercises on balance in persons post-stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 May;24(4):228-235. doi: 10.1080/10749357.2016.1251742. Epub 2016 Nov 3.

    PMID: 27808012BACKGROUND
  • Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.

    PMID: 29061169BACKGROUND

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 1, 2021

Study Start

February 15, 2020

Primary Completion

October 20, 2020

Study Completion

December 30, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations