NCT05087719

Brief Summary

To determine effects of proprioceptive activities on hand function in chronic stroke patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 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

October 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 12, 2021

Last Update Submit

October 12, 2021

Conditions

Keywords

graphesthesiastereognosisstroke

Outcome Measures

Primary Outcomes (3)

  • wolf motor assessment scale

    The scale was categorized from 0-5.0 represents that UE doesn't attempt tested.1 represents that the UE being tested does not participate functionally.2 represents that UE does movements minor readjustment or change in position, but requires assistance.3 represents UE does movement but movements is effected to certain degree by synergy or performance gradually or with effort.4 represents that movement was close to normal slight slower lack accuracy.5 represents that movement seems to be accurate

    15 minutes

  • Byl-Cheney-Boczai Sensory Discriminator Test

    For the stereognosis

    15 minutes

  • Graphesthesia (modified sub test of sensory integration praxis test)

    to assess Graphesthesia

    15 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

The patients in the experimental group will get the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints, therapist repeatedly draw some letter, figures, digit, shapes ,alphabets on the palm of hand/digits of patient.For Stereognosis therapist command the patient to close his or her eyes, then on affected hand put some different kinds of objects and shapes then ask the patient to identify that object, the object might be of any kind like a key, rubber a block or a coin etc. Total time for stereognosis was 15 minutes. For motor training patients were guided by the therapist to use his or her affected hand more. Then patient practiced some task like drawing writing his or her name, folding the towel or a paper, eating something with different speed, picking small objects like nails and put them in to small boxes, organize the cards etc. This training session required 15 minutes.

Combination Product: experimental group

conventional treatment

ACTIVE COMPARATOR

baseline treatment of hot pack for 15 minutes will be given.The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist.

Combination Product: conventional treatment

Interventions

experimental groupCOMBINATION_PRODUCT

patients will receive the hot pack initially for 15 minutes .Then for proprioception training of graphesthesia for 15 mints,stereognosis will be of 15 minutes. For motor training patients will practice 15 mints motor tasks

experimental group
conventional treatmentCOMBINATION_PRODUCT

patients will receive the baseline treatment of hot pack for 15 minutes. The patients in this group will get muscle strengthening exercise of the hand, Range of motion, and stretching of the hand muscles, 3 sets of 8 repetitions were given to the patient, gap of 2 minutes will be given between regimes. For 20 minutes this session will be given to patient by the therapist.

conventional treatment

Eligibility Criteria

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

You may qualify if:

  • Either right or left sided hemiplegic patients post stroke 6 months to 4 years
  • Can partially open and close hand and able to elevate arm to at least 60 degrees and bend to 45-60 degree against gravity.

You may not qualify if:

  • Patient with TBI, neuromuscular degenerative diseases, diabetes, heart disease, fracture of hand ,.muscular skeletal injuries of hand or birth deformities of hand
  • Patients having any known or diagnosed psychological condition or unable to follow the command for exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

  • Wu CY, Fu T, Lin KC, Feng CT, Hsieh KP, Yu HW, Lin CH, Hsieh CJ, Ota H. Assessing the streamlined Wolf motor function test as an outcome measure for stroke rehabilitation. Neurorehabil Neural Repair. 2011 Feb;25(2):194-9. doi: 10.1177/1545968310381249. Epub 2010 Oct 14.

    PMID: 20947494BACKGROUND
  • Turville ML, Cahill LS, Matyas TA, Blennerhassett JM, Carey LM. The effectiveness of somatosensory retraining for improving sensory function in the arm following stroke: a systematic review. Clin Rehabil. 2019 May;33(5):834-846. doi: 10.1177/0269215519829795. Epub 2019 Feb 25.

    PMID: 30798643BACKGROUND
  • Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.

    PMID: 27679565BACKGROUND

MeSH Terms

Conditions

StrokeSomatosensory Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • zeest hashmi, MS NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 21, 2021

Study Start

October 15, 2020

Primary Completion

July 15, 2021

Study Completion

August 15, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations