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Outcome Measures

Primary Outcomes (1)

Activities-Specific Balance Confidence (ABC) Scale
This questionnaire measures an individual's perception of their own balance. Individuals use a scale ranging from 0% to 100% in rating the amount of confidence they have in their balance during 16 hypothetical daily-life activities. A score of 100% would represent one being fully confident in their balance during a specific task, while a score of 0% would represent one having no confidence at all in their balance. Total score ranges from 0 to 1600.
Collected at a participant's baseline visit and final study visit, after an average of one month

Secondary Outcomes (1)

Gait speed
Collected at a participant's baseline visit and final study visit, after an average of one month

Study Arms (2)

Feedback-assisted physical therapy

ACTIVE COMPARATOR

During a visual feedback session, therapists will spend 30min per session using the Mobility Rehab system for gait training with patients. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks.

Other: Feedback-assisted physical therapy

Traditional physical therapy

PLACEBO COMPARATOR

During a regular session, patients with gait impairment will work on gait with the following tasks for 30min: weights on ankles, dual tasks, UE support, partial body weight support, speed challenges, obstacles, and head turning. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks.

Other: Traditional physical therapy

Interventions

Feedback-assisted physical therapyOther

The system uses unobtrusive, wearable, inertial sensors with real-time algorithms to provide real-time feedback on: step time asymmetry, foot clearance, arm swing, trunk lateral range, and foot strike angle during gait.

Feedback-assisted physical therapy

Traditional physical therapyOther

Therapists will treat these patients with traditional therapeutic modalities and practices.

Related Publications (2)

Silva-Batista C, Harker G, Vitorio R, Studer M, Whetten B, Lapidus J, Carlson-Kuhta P, Pearson S, VanDerwalker J, Horak FB, El-Gohary M, Mancini M. Mobility Rehab visual feedback system for gait rehabilitation in older adults. J Neuroeng Rehabil. 2023 Oct 24;20(1):144. doi: 10.1186/s12984-023-01260-2.

PMID: 37875971DERIVED

Vitorio R, El-Gohary M, Pearson S, Carlson-Kuhta P, Harker G, Horak FB, Lapidus J, Studer M, Mancini M. Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial. Front Neurol. 2021 Sep 6;12:680637. doi: 10.3389/fneur.2021.680637. eCollection 2021.

PMID: 34552549DERIVED

MeSH Terms

Conditions

Parkinson DiseaseStrokeMultiple SclerosisGait Disorders, NeurologicGait Ataxia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCerebrovascular DisordersVascular Diseases

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

Directing physical therapist will assess eligibility, and randomize participants. Physical therapy aide will conduct baseline measures (questionnaires, ABC scale, and 2min walk). The four treating physical therapists are split into two groups: two therapists will provide traditional physical therapy, while the two other therapists will provide visual feedback-aided therapy for their participants. A second, blinded physical therapy aide will complete a follow-up assessment (ABC scale, 2min walk).

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Eligible participants are randomized into two groups. One group will receive standard physical therapy for their gait or balance issue while the other will receive visual feedback-aided physical therapy.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Assistant Professor

Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Feedback-assisted physical therapy

Traditional physical therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Feedback-assisted physical therapy

Traditional physical therapy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations