NCT05490797

Brief Summary

To determine the effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

August 4, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

Stroke, IschemicSkill, SocialOcclusion

Outcome Measures

Primary Outcomes (4)

  • The Nine Hole Peg Test (NHPT)

    The Nine Hole Peg Test (NHPT) is designed to quantify finger dexterity with neurological diagnoses patients.

    9 months

  • Fugl-Meyer Motor assessment (FMA)

    Fugl-Meyer Motor assessment (FMA) is specific for post stroke performance based on impairment index. This is specific for quantification of balance and motor functioning.

    9 months

  • The Box &Block Test (BBT)

    The Box \&Block Test (BBT) is designed for measuring overall manual dexterity.

    9 months

  • hand dynamometer.

    Grip strength is assessed using a hand dynamometer.

    9 months

Study Arms (2)

app based training with conventional therapy

EXPERIMENTAL

In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy.

Other: app based training with conventional therapy

conventional therapy

ACTIVE COMPARATOR

The control group will receive conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise)

Other: conventional therapy

Interventions

The experimental group will receive an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function.

app based training with conventional therapy

conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise)

conventional therapy

Eligibility Criteria

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

You may qualify if:

  • Six months to 2 years post stroke
  • Participants must be able to open and close their fingers (even only 2 cm of movement)
  • Before stroke there must be fully functional hand
  • Normal or intact vision

You may not qualify if:

  • Neurological disorders other than stroke for example multiple sclerosis or Parkinson disease.
  • Upper extremities acute orthopaedic conditions.
  • Any cardiopulmonary complications
  • Medically unstable patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (4)

  • Lanas F, Seron P. Facing the stroke burden worldwide. Lancet Glob Health. 2021 Mar;9(3):e235-e236. doi: 10.1016/S2214-109X(20)30520-9. Epub 2021 Jan 7. No abstract available.

    PMID: 33422188BACKGROUND
  • Doumas I, Everard G, Dehem S, Lejeune T. Serious games for upper limb rehabilitation after stroke: a meta-analysis. J Neuroeng Rehabil. 2021 Jun 15;18(1):100. doi: 10.1186/s12984-021-00889-1.

    PMID: 34130713BACKGROUND
  • Olsen TS. Arm and leg paresis as outcome predictors in stroke rehabilitation. Stroke. 1990 Feb;21(2):247-51. doi: 10.1161/01.str.21.2.247.

    PMID: 2305400BACKGROUND
  • Jensen M, Thomalla G. Causes and Secondary Prevention of Acute Ischemic Stroke in Adults. Hamostaseologie. 2020 Feb;40(1):22-30. doi: 10.1055/s-0039-1700502. Epub 2019 Oct 24.

    PMID: 31648355BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeSocial SkillsBites and Stings

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSocial BehaviorBehaviorPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • zeest hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: total 22 participants will be enrolled. In experimental group app based training will be performed along with conventional hand fine motor skills and dexterity therapy. Conventional hand therapy will be given to the second group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

January 1, 2022

Primary Completion

August 20, 2022

Study Completion

August 20, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations