NCT06292481

Brief Summary

The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

January 28, 2024

Last Update Submit

March 4, 2024

Conditions

Keywords

Brunnstorm movement therapyHand dexterityLow-level laser therapyStroke

Outcome Measures

Primary Outcomes (5)

  • Fugle meyer Assessment test

    6th week

  • Box and block test

    6th week

  • Nine peg hole test

    6th week

  • to check Muscle tone

    Modified Ashworth Scale

    6th week

  • to measure grip Strength

    Hand handled dynamometer

    6th week

Study Arms (2)

Brunnstorm Movement therapy

EXPERIMENTAL

this group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks

Other: Brunnstorm movement therapy

Combined Brunnstorm Movement therapy and low level laser therapy

EXPERIMENTAL

this group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks

Other: Combined Brunnstorm Movement therapy and low level laser therapy

Interventions

this group received Brunnstorm Movement therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks

Brunnstorm Movement therapy

this group received Combined Brunnstorm Movement therapy and low level laser therapy for 3 to 5 sessions per week, each lasting approximately 30 to 60 minutes for 6 weeks

Combined Brunnstorm Movement therapy and low level laser therapy

Eligibility Criteria

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

You may qualify if:

  • Age range between 40 \& 60 years (16)
  • Both males and females.
  • Combined Effects of Brunnstorm movement therapy and LLLT on Upper limb function Hand dexterity in stroke
  • Patient with maximum Grade 1 and 1+ spasticity according to Modified
  • Ashworth scale and minimum muscle strength of 1 in the biceps brachii muscle.
  • Onset of injury : (1 to 2 years)

You may not qualify if:

  • Any comorbidity such as malignancy, inflammatory rheumatologic disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus erythematosus, etc.
  • Have a pacemaker or a history of serious cardiac events or of cardiorespiratory dysfunction.
  • Visual impairment
  • Any other musculoskeletal disorders of extremity
  • Severe cognitive impairment or aphasia leading to difficulty in communication, Participants unwilling to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Govt. Mian Munshi DHQ Teaching hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • das Neves MF, Aleixo DC, Mendes IS, Lima FPS, Nicolau RA, Arisawa EAL, Lopes-Martins RAB, Lima MO. Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial. Lasers Med Sci. 2020 Sep;35(7):1459-1467. doi: 10.1007/s10103-019-02920-3. Epub 2019 Dec 10.

    PMID: 31823135BACKGROUND
  • da Silva BP, Souza GADS, Filho AADN, Pinto AP, Guimaraes CL, Pereira APC, Neves MFD, Martins PSLL, Lima FPS, Lopes-Martins RAB, Lima MO. Analysis of the effects of low-level laser therapy on muscle fatigue of the biceps brachii muscle of healthy individuals and spastic individuals: Study protocol for a single-center, randomized, double-blind, and controlled clinical trial. Medicine (Baltimore). 2019 Sep;98(39):e17166. doi: 10.1097/MD.0000000000017166.

    PMID: 31574822BACKGROUND
  • Azuma RHE, Merlo JK, Jacinto JL, Borim JM, da Silva RA, Pacagnelli FL, Nunes JP, Ribeiro AS, Aguiar AF. Photobiomodulation Therapy at 808 nm Does Not Improve Biceps Brachii Performance to Exhaustion and Delayed-Onset Muscle Soreness in Young Adult Women: A Randomized, Controlled, Crossover Trial. Front Physiol. 2021 Jun 10;12:664582. doi: 10.3389/fphys.2021.664582. eCollection 2021.

    PMID: 34177615BACKGROUND
  • Stamborowski SF, de Oliveira Spinelli BM, Lima FPS, Costa DR, de Silveira Souza GA, Lima MO, Lopes Martins RAB. The influence of photobiomodulation on the temperature of the brachial biceps during muscle fatigue protocol. Lasers Med Sci. 2021 Oct;36(8):1741-1749. doi: 10.1007/s10103-021-03360-8. Epub 2021 Jul 13.

    PMID: 34255219BACKGROUND
  • Vassao PG, Baldini GS, Vieira KVSG, Balao AB, Pinfildi CE, Campos RMDS, Tucci HT, Renno ACM. Acute Photobiomodulation Effects Through a Cluster Device on Skeletal Muscle Fatigue of Biceps Brachii in Young and Healthy Males: A Randomized Double-Blind Session. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):773-779. doi: 10.1089/photob.2019.4786.

    PMID: 33332234BACKGROUND
  • Harada T, Miyagi M, Izukura H, Endou G, Ushigome N, Tsuruoka H, Mizutani A, Ohshiro T, Ebihara S. The effect of low level laser therapy for pain in major muscles controlling two joints. Laser Ther. 2019 Jun 30;28(2):111-115. doi: 10.5978/islsm.19-OR-07.

    PMID: 32921909BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 28, 2024

First Posted

March 5, 2024

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 10, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations