Under and Over Rehabilitation Study

NCT04490044 | Completed

• 1 other identifier: 285101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a progressive neurological condition of the central nervous system for which there is no cure. Symptoms include motor and sensory dysfunction, bladder and bowel dysfunction as well as speech and swallowing difficulties. It commonly leads to cumulative, mixed disabilities over time. The combination of different symptoms and disabilities often limits a person's ability to perform activities of daily living and to actively participate in social and occupational activities which then impacts on their quality of life. The two main strategies for managing MS symptoms include, medication and rehabilitation. However, historically treatment strategies have focused predominantly on preserving lower limb function thus strategies to improve upper limb function is often neglected. The importance of maintaining upper limb (hand and arm) function is significant for people who have already lost lower limb function. Further loss of functioning contributes to low mood, reduced independence and quality of life. This study aims to research how an engaging everyday activity, Under \& Over, can become a rehabilitation tool to improve upper limb function in people with MS. The study will use a randomised wait list control group design, meaning that participants will be randomised to either the immediate rehabilitation group or the wait list group. Each group will perform the Under \& Over task for 12 weeks, following a predetermined programme of instructions. Participants will complete a number of baseline measures measuring their current upper limb function, their quality of life and level of fatigue. This will happen at the start of the study, after 12 weeks of rehabilitation activity and again at a 12 week follow up.

Conditions

Multiple Sclerosis

Keywords

rehabilitation; design

Outcome Measures

Primary Outcomes (1)

• Change in Cardboard 9 Hole Peg Test speed at 6 months.

  The primary outcome measure will be the self-administered Cardboard Nine Hole Peg Test (c9HPT), the raw scores are times to complete the standard task used in the assessment. The aim is to determine if repeated use of the Under \& Over tool can improve upper limb function for people with MS using the cardboard nine hole peg test. Raw 9HPT times are skewed rather than normal (Gaussian), but transforming the task times by taking their reciprocal (1/time) leads to an approximately normally distributed measure, and in this form 9HPT is standardly analysed. This reciprocal is readily interpreted as task speed: e.g. if a patient takes 25 seconds to complete the task, the reciprocal, 0.04, is the fraction of the 9HPT task achieved in one second, ie. 4%.

  Baseline and 6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Participants in Arm 1 will be posted the Under \& Over study pack (1) and asked to complete the Under \& Over tool daily for up to 30 minutes per day, 5 days per week for 3 months. They will be instructed to follow the instruction booklet and complete each pattern in the specific order described in the booklet.

Other: Under & Over rehabilitation tool

2

ACTIVE COMPARATOR

Participants in Arm 2 will be posted the Under \& Over study pack (2) and asked to complete the Under \& Over tool daily for as long or short as they choose or are able to. They will be asked to complete 5 days per week for 3 months. They will be instructed to follow the instruction booklet in any order they wish, choosing which pattern they would like to complete. They will also be encouraged to create their own patterns. These participants will have access to a section of the study website where they will be able to upload photographs of their patterns and see other participants' patterns over the 3-month period.

Other: Under & Over rehabilitation tool

3

PLACEBO COMPARATOR

Participants in Arm 3 will be posted the Under \& Over study pack (3). For the first three months of the study they will be asked to complete the c9HPT 5 days a week. After three months, they will be able to complete the Under \& Over tool daily for as long or short as they choose. Similar to Arm 2, They will be asked to do this 5 days per week for 3 months. They will be instructed to follow the instruction booklet in any order they wish, choosing which pattern they would like to

Other: Under & Over rehabilitation tool

Interventions

Under & Over rehabilitation tool OTHER

Under \& Over is a tool consisting of a 40cm x 40cm white plastic board, two coloured laces and a series of patterns to complete. It enables people to create patterns by threading each lace under, and over the board. It has been designed and developed with people whose upper limb function is affected by their MS. Administration time can be dependent on the person completing it.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being able to give online informed consent.
• Over the age of 18. There is no upper age limit.
• Have been diagnosed with Multiple Sclerosis more than 6 months ago and have an Expanded Disability Status Scale (EDSS) of over 6.0 as measured using the online webEDSS
• Understand and be able to communicate (read and write) in English
• Ability to use a computer and access the study resources on the internet

You may not qualify if:

• Patients unable to use their hands because of pain or anything that would interfere with the ability to complete the study interventions.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Roche Pharma AG: collaborator
• Barts & The London NHS Trust: collaborator

Study Sites (1)

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomisation will be done by the researcher and will be blinded to participants' identification.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following enrolment and baseline testing participants will be randomised into one of three study arms (Arm 1, Arm 2, Arm 3) and emailed instructions on how to proceed.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: September 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 18, 2022

Record last verified: 2020-07

Locations

GB (1)